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NIMH Clinical Research Toolbox

The NIMH Clinical Research Toolbox serves as an information repository for NIMH staff and the clinical research community, particularly those receiving NIMH funding. The Toolbox contains resources such as NIH and NIMH policy and guidance documents, templates, sample forms, links to additional resources, and other materials to assist clinical investigators in the development and conduct of high-quality clinical research studies.

Use of these templates and forms is optional; the resources can be used as-is or customized to serve study team needs. In cases where institutions provide research teams with institution-specific templates and forms for clinical research documentation, NIMH expects researchers to follow their institutional policies for document use. Nevertheless, the materials on this page can be consulted to assure that study teams are meeting NIMH expectations.

Protocol Templates

Protocol associated documents, regulatory documents and associated case report forms, clinical research education, support, and training (crest) program overview.

• Human Subject Risk

Data and Safety Monitoring for Clinical Trials

Reportable events, recruitment, suicide prevention research, good clinical practice training, data sharing, educational presentations, clinical research start up.

NIMH encourages investigators to consider using one of the protocol templates below when developing a clinical research protocol. In cases where an institutional review board (IRB) has a recommended or required protocol template, reviewing the documents included below is still suggested as there may be sections that a study team may opt to include in an effort to develop a comprehensive research protocol.

NIH has developed a Clinical e-Protocol Writing Tool  to support the collaborative writing and review of protocols for behavioral and social sciences research involving humans, and of phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application.

NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template  

This clinical trial protocol template is a suggested format for Phase 2 and 3 clinical trials funded by NIH that are being conducted under a FDA IND or IDE Application.

Investigators for such trials are encouraged to use this template when developing protocols for NIH-funded clinical trial(s). This template may also be useful to others developing phase 2 and 3 IND/IDE clinical trials.

NIH Behavioral and Social Clinical Trials Template  

This clinical trial protocol template is a suggested format for behavioral or psychosocial clinical trials funded by NIH. Investigators for such studies are encouraged to use this template when developing protocols for NIH-funded clinical trial(s). This template may also be useful to others developing behavioral of psychosocial research studies.

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NIMH Clinical Manual of Procedures (MOP) Template [Word]

This template provides a recommended structure for developing consistent instructions on study procedure implementation and data collection across participant and clinical site activities. It details the study’s organization, operations, procedures, data management, and quality control.

NIMH Clinical Monitoring Plan Template [Word]

This template provides a recommended structure for a plan to conduct internal or independent review of Good Clinical Practices (GCP), human subject safety, and data integrity throughout the lifecycle of a study.

Informed Consent Materials

Often study teams will be provided with informed consent form templates and guidance on requirements for the informed consent process by their institutions. Below is additional guidance and materials to support a thorough informed consent process.

Sample NDA Informed Consent Language

The NIMH Data Archive (NDA) receives de-identified human subjects data collected from hundreds of research projects across many scientific domains, and makes these data available to enable collaborative science. This NDA sample informed consent language for data sharing can be adapted when using one of the NDA platforms.

Regulatory Document Checklists by Study Type The following checklists are intended to help the investigator community identify a set of core documents to be organized within a single study specific folder, either electronically, hard copy, or a mixture of both formats. NIMH encourages study teams to verify what additional documents, or alternative formats of the documents in the checklists, their institution and IRB require.

NIMH Regulatory Document Checklist for non-Clinical Trial Human Subjects Research [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded study that does not meet the NIH definition of a clinical trial  and is research on human subjects.

NIMH Regulatory Document Checklist for Clinical Trials without Investigational Product [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded NIH defined clinical trial  that does not involve an investigational drug or device.

NIMH Regulatory Document Checklist for Human Subjects Research Clinical Trials with Investigational Product not under a FDA IND/IDE [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded NIH defined clinical trial  with an investigational drug or device that is not under a FDA IND or IDE.

NIMH Regulatory Document Checklist for a Study under a FDA IND or IDE [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded NIH defined clinical trial  or non-clinical trial with an investigational drug or device under a FDA IND or IDE.

Necessary Documents for Reportable Events

NIMH Reportable Events Log Template [Word]

This document provides a log template for documenting reportable events. The types of events that require reporting may vary by institution, IRB, sponsor, state, and other factors.

NIMH Study-Wide Protocol Deviation Log Template [Word]

This document provides a log template for tracking all protocol deviations/violations across a study.

NIMH Subject-Specific Protocol Deviation Log Template [Word]

This document provides a log template for tracking subject-specific protocol deviations/violations. If captured electronically, subject-specific deviation logs can be exported into a study-wide deviation log.

NIMH Study-Wide Adverse Events (AE) Log Template [Word]

This document provides a log template for tracking all adverse events (AEs), including serious adverse events (SAEs), across a study.

NIMH Subject-Specific Adverse Event (AE) Log Template [Word]

This document provides a log template for tracking adverse events (AEs), including serious adverse events (SAEs), for each subject. If captured electronically, subject-specific AE logs can be exported into an electronic study-wide AE log.

Necessary Documents for Studies with Pharmacy/Investigational Product

FDA Form 1572 Statement of Investigator  

This FDA form should be signed by the investigator prior to study initiation to provide certain information to the sponsor, and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic.

NIMH Investigational Product (IP) Management Standard Operating Procedure (SOP) Template [Word]

This document provides a sample standard operating procedures (SOP) template to document how investigational product (IP) will be received, stored, monitored, labeled, dispensed, and destroyed.

NIMH Investigational Product Storage Temperature Log Template [Word]

This document provides a log template for recording the daily temperatures for investigational product (IP).

NIMH Master Investigational Product Dispensing and Accountability Log Template [Word]

This document provides a log template for capturing all investigational product (IP) dispensed to and returned by participants for the duration of the study.

NIMH Subject-Specific Investigational Product Dispensation and Accountability Log Template [Word]

This document provides a log template for capturing all investigational product (IP) dispensed to an individual participant and returned by that participant. This log is typically placed in each subject’s study binder (study blind is maintained, if applicable).

Screening and Enrollment Logs and Materials

NIMH Participant Pre-Screening Log Template [Word]

This document provides a log template for all potential participants who have completed initial screening procedures (i.e. phone screens or internet screening surveys; typically, prior to signing written informed consent). This log should capture the number of participants eligible for an official screening visit, as well as the number ineligible with the reasons for ineligibility listed.

NIMH Participant Enrollment Log Template [Word]

This document provides a log template for chronologically documenting the participants who have been enrolled in the study.

NIMH Inclusion/Exclusion Checklist Template [Word]

This document provides a sample checklist to customize according to protocol-specific eligibility criteria. A qualified and appropriately-delegated study team member should sign and date to confirm eligibility once all criteria have been assessed. If criteria are assessed on different visit dates, this checklist should be reformatted to reflect which criteria are assessed on which visit dates, and who is responsible for assessing them.

NIMH Documentation of Informed Consent Template [Word]

This document provides a sample form template for documenting the informed consent process.

Additional Participant Tracking Logs and Materials

NIMH Concomitant Medication Log Template [Word]

This document provides a log template for recording each participant’s medications throughout the study. This log is typically reviewed at all subject study visits and is located in each participant’s study binder.

NIMH Research Sample Inventory/Tracking Log [Word]

This document provides a log template for tracking the collection and storage of research samples.

Staff Training and Administrative Tracking Logs and Materials

NIMH Good Clinical Practice (GCP) Training Log Template [Word]

This document provides a log template for documenting completion of Good Clinical Practice (GCP) training requirements. Note: all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). Individual institutions may require GCP training regardless of funding source or clinical trial status.

NIMH Study Training Log Template [Word]

This document provides a log template for documenting staff trainings for study-specific procedures (i.e., trainings for diagnostic interview administration, study protocol adherence, phlebotomy, outcomes measures, OSHA Bloodborne Pathogens, etc.).

NIMH Delegation of Authority Log Template [Word]

This document can be used to record all study staff members’ significant study-related duties, as delegated by the Principal Investigator (PI). Most studies opt to use a log format, such as the Delegation of Authority log, because it captures study staff on one page and includes space to document the addition or removal of specific study tasks for individual staff members.

NIMH Monitoring Visit Log Template [Word]

This document is typically completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.

NIMH Note to File (NTF) Template [Word]

This document provides a sample template for generating notes-to-file, which are written to acknowledge a discrepancy or problem with the study’s conduct, or for other administrative purposes (such as to document where study materials are stored).

On-Site Monitoring

Even though it is the NIMH’s expectation that grantees will provide adequate oversight of their clinical research, NIMH Program Officials may require additional levels of on-site monitoring conducted by NIMH staff. Clinical monitoring helps ensure the rights and well-being of human subjects are protected; the reported clinical research study data are accurate, complete, and verifiable; and the conduct of the study is in compliance with the study protocol, Good Clinical Practice (GCP), and the regulations of applicable agencies.

The NIMH Clinical Research Education, Support, and Training (CREST) Program provides ongoing educational and technical support from NIMH staff for clinical research project grants selected for consultation and/or site visit(s). The CREST Program aims to ensure that the reported clinical research study data are accurate, complete, and verifiable, the conduct of the study is in compliance with the study protocol, Good Clinical Practice (GCP) and the regulations of applicable agencies, and the rights and well-being of human subjects are protected, in accordance with 45 CFR 46 (Protection of Human Subjects) and, as applicable, 21 CFR part 50 (Protection of Human Subjects).

To promote clinical research that is compliant with GCP and human subject regulations, the CREST Program includes phone conversations, email consultation, and/or site visit(s) from NIMH staff, as needed, to assess and provide written feedback and recommendations on planned or ongoing clinical research protocols. Documents relating to the conduct of the clinical research, such as current IRB approved protocols, informed consent documents, source documents, and drug accountability records, as applicable, may be reviewed for compliance with applicable Federal regulations, and institutional and IRB policies.

Research project grants selected for inclusion in the CREST Program might include clinical research studies with “significantly-greater-than-minimal risk” to subjects (e.g., an intervention or invasive procedure with high potential for serious adverse events; see NIMH Risk-Based Monitoring Guidance ); a study intervention under a FDA Investigational New Drug or Investigational Device Exemption; or other studies identified by NIMH staff that may benefit from inclusion in CREST. CREST is separate and distinct from “for cause” audits of clinical research. Research grants may be included in CREST at any time during the study lifecycle, although projects are generally identified and selected for the program at the initiation of the grant.

NIMH Clinical Research Education Support and Training (CREST) Program Overview

This page provides a description of the NIMH CREST Program’s purpose, process for inclusion, and operating procedures.

Site Visits

NIMH Clinical Research Education, Support, and Training Program (CREST): Comprehensive Visit Report Template [Word]

This template provides a recommended structure for a CREST site visit report, as well as a sample matrix of regulatory criteria that CREST monitors look at while at site initiation visits (SIVs), interim monitoring visits (IMVs) and close out visits (COVs). It is to be used as a starting point for preparing for a CREST site visit or for writing a site visit report.

NIMH CREST Site Initiation Visit (SIV) Sample Agenda [Word]

This document provides a sample site initiation visit agenda to be customized by the Principal Investigator (PI) and site monitor prior to the visit.

Human Subjects Research

This section provides resources, including policy and guidance documents related to the conduct of human subject research. The resources included below represent those frequently of interest to NIMH investigators, specifically: overviews of human subject research, data and safety monitoring, human subject risk, reportable events, and recruitment. There are numerous other NIH webpages devoted to human subjects research; see Research Involving Human Subjects  , NIH Human Subjects Policies and Guidance  , and New Human Subjects and Clinical Trial Information Form  .

Human Subject Regulations Decision Charts 

The Office for Human Research Protections (OHRP) has developed graphic aids to help guide investigators in deciding if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations ( 45 CFR 46  ).

Human Subjects in Research: Things to Consider

This NIMH webpage presents items which investigators should pay particular attention to when proposing to use human subjects in NIMH-funded studies.

Human Subjects Risk

NIMH Guidance on Risk-Based Monitoring

This NIMH guidance aims to clarify risk level definitions and the NIMH’s monitoring expectations to mitigate these risks. This guidance will assist study teams in determining the level of data and safety monitoring that should be established for a study based on the probability and magnitude of anticipated harm and discomfort.

The policies, guidance and documentation in this section outline NIMH expectations for data and safety monitoring of clinical trials  . For human subject research that does not meet criteria for NIH clinical trial designation, investigators still have an option of including a data and safety monitoring plan (DSMP; i.e., in studies that may have significant risk to participants). The initial links below apply to all NIMH-funded clinical trials, while the second section provides documentation for clinical trials under the oversight of a NIMH-constituted data and safety monitoring board (DSMB).

All Clinical Trials

NIMH Policy Governing the Monitoring of Clinical Trials

This NIMH policy outlines NIH and NIMH expectations for data and safety monitoring of clinical trials. This policy also assures that the NIMH is notified by NIMH-funded researchers in a timely manner of all directives emanating from monitoring activities.

Guidance for Developing a Data and Safety Monitoring Plan for Clinical Trials Sponsored by NIMH

This guidance was created to aid investigators developing a data and safety monitoring plan (DSMP) to ensure the safety of research participants and to protect the validity and integrity of study data in clinical trials supported by NIMH. This guidance applies to data and safety monitoring for all NIMH-supported clinical trials (including grants, cooperative agreements, and contracts).

NIMH Policy Governing Independent Safety Monitors and Independent Data and Safety Monitoring Boards

This policy establishes expectations for the monitoring of NIMH-supported clinical trials by Independent Safety Monitors (ISMs) and/or independent data and safety monitoring boards (DSMBs) to assure the safety of research participants, regulatory compliance, and data integrity.

Trials Reviewed by a NIMH-Constituted DSMB

The materials below are for studies designated for review by a NIMH-constituted DSMB. Study teams developing materials for a study-constituted independent DSMB may benefit from reviewing the data report template and the protocol amendment memo.

NIMH Clinical Trials Operations Branch Liaison Orientation Letter [Word]

This letter provides an orientation to working with the NIMH Clinical Trials Operations Branch which supports study teams reporting to the NIMH DSMB.

NIMH DSMB Reporting Guide Full Report Template [PDF]

This template provides a recommended structure for data reports used for DSMB review and oversight. The report template includes standard data tables. Study teams are encouraged to utilize this template as a starting point, and use, remove, and/or modify the existing tables as appropriate for the study under review.

NIMH DSMB Amendment Memo Template [Word]

This template may be used when submitting a study protocol or consent document amendment to the NIMH DSMB.

NIMH Reportable Events Policy

This policy outlines the expectations of NIMH-funded researchers relating to the submission of reportable events (i.e., Adverse Events  (AEs); Serious Adverse Events  (SAEs); Unanticipated Problems Involving Risks to Subjects or Others  ; protocol violations; non-compliance  (serious or continuing); suspensions or terminations by monitoring entities  (i.e., Institutional Review Board (IRB), Independent Safety Monitor (ISM)); and suspensions or terminations by regulatory agencies (i.e., Office for Human Research Protections  (OHRP) or the Food and Drug Administration (FDA)).

( For associated documentation, see: Guidance on Regulatory Documents and Associated Case Report Forms )

NIMH Policy for the Recruitment of Participants in Clinical Research

This policy is intended to support effective and efficient recruitment of participants into all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size.

NIMH Recruitment of Participants in Clinical Research Policy

This policy outlines NIMH expectations regarding the establishment of recruitment plans and milestones for overall study enrollment, and as appropriate, recruitment plans for females and males, members of racial and ethnic minority groups, and children, as well as recruitment reporting.

Frequently Asked Questions (FAQ) about Recruitment Milestone Reporting (RMR)

This NIMH FAQ document provides responses to several of the most common questions surrounding RMR.

Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study

These “points to consider” are meant to serve as a resource as investigators plan a clinical research study and a NIMH grant application. It also outlines common barriers that can impact clinical recruitment and retention.

Additional Resources and Trainings

Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers

This web document is intended to support the development of NIMH research grant applications in suicide research, including those related to clinical course, risk and detection, and interventions and implementation, as well as to support research conduct that is safe, ethical and feasible.

Based on the NIH Good Clinical Practice (GCP) policy  , all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials are requirement to be trained in GCP. Below are links to some GCP courses that meet NIH GCP training expectations.

Good Clinical Practice for Social and Behavioral Research – E-Learning Course 

The NIH Office of Behavioral and Social Sciences Research (OBSSR) offers a self-paced Good Clinical Practice (GCP) training course with nine video modules. Learners complete knowledge checks and exercises throughout the course.

National Institute of Allergies and Infectious Diseases (NIAID) GCP Learning Center 

NIAID has created a self-paced Good Clinical Practice (GCP) training course that includes four modules. These modules educate the learner on the history of human subject research, the regulatory framework, planning human subject research, and conducting human subject research.

National Drug Abuse Treatment (NDAT) Clinical Trials Network  

This NDAT course includes 12 modules based on International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and the Code of Federal Regulations (CFR) for clinical research studies in the U.S. The course is self-paced and takes approximately six hours to complete.

The following notices and links present NIMH expectations and tools for data sharing.

Data Sharing Expectations for NIMH-Funded Clinical Trials 

This notice establishes NIMH’s data sharing expectations, including the request to include a detailed data sharing plan as part of grant applications.

Data Harmonization 

This notice encourages investigators in the mental health research community to utilize data collection protocols using a common set of tools and resources to facilitate sharing, comparing, and integration of data from multiple sources.

NIMH Data Archive 

The NIMH Data Archive is an informatics platform for the sharing of de-identified human subject data from all clinical research funded by the NIMH.

Educational Materials

The following educational materials are provided to support the training of NIMH-funded clinical research investigators and staff.

Good Clinical Practices (GCP) for NIMH-Sponsored Studies [PowerPoint]

This training presentation defines Good Clinical Practice (GCP) and describes its application in NIMH-funded research. Topics include: investigator responsibilities, training and qualifications, resources and staffing, delegation of responsibilities, informed consent, documentation and storage of data, assessment and reporting, protocol adherence, drug accountability, adverse events/unanticipated problems and noncompliance. Note that this presentation does not replace the Good Clinical Practice (GCP) training required for NIH funded investigators.

Good Documentation Practices for NIMH-Sponsored Studies [PowerPoint]

This training presentation provides an overview of good documentation practices to follow throughout the duration of NIMH-funded research. The presentation defines and gives examples of good documentation practices.

Introduction to Site-Level Quality Management for NIMH-Sponsored Studies [PowerPoint]

This training presentation provides an overview of the process of establishing and ensuring the quality of processes, data, and documentation associated with clinical research activities. Quality Management (QM) is defined in relationship to site-level documentation, processes, and activities. Tools that are available to support site-level QM are also described.

NIMH Clinical Monitoring and Clinical Research Education, Support, and Training Program (CREST) Overview [PowerPoint]

This training presentation provides an overview of Clinical Monitoring, types of site monitoring visits and what takes place during these visits as well as an overview of follow-up activities. The presentation specifically describes the NIMH Clinical Research Education Support and Training (CREST) Program, its goals, study portfolio selection process, and standard procedures.

Additional NIMH Links and Contacts:

• Office of Clinical Research
• Clinical Trials Operations Branch (CTOB)
• NIMH Clinical Research Policies, Guidance, and Resources
• Human Research Protection Branch (HRPB)

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Downloadable Templates and Tools for Clinical Research

Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

These templates and tools are ordered by category, so please scroll down to find what you need.

To share your own templates and SOPs, or comment on these, please email [email protected]. We look forward to hearing from you!

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Trial Operations    Trial Management    Ethics and Informed Consent    Resources    Trial Design    Data Management and Statistics   

training   

This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

i was wondering why there is no SOP on laboratory procedures ?

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

Thank you for sharing the resources. It is very kind of you.

Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

Thank you for your kind comments.

Fantastic resources

I am delighted you found this website. I earlier introduced it to you because of your prolific interest in health care information and resource sharing....

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Interventional Studies - Planning & Startup

On this page, clinical terms of award, protocol template, planning & site activation, data management, essential documents binder, informed consent, manual of operations, data & safety monitoring (dsmb, medical monitor, independent safety monitor), clinical site monitoring, quality management, overview .

If you are an NIDCR grant applicant or awardee planning to conduct an interventional study, you may need the following documents. Questions? Contact [email protected] or your NIH Program Official.

NIDCR Data and Safety Monitoring Board (DSMB)

Nidcr medical monitor, nidcr independent safety monitor.

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Site Monitoring Visit Overview

The purpose of site monitor visits is to ensure compliance with study protocol, and standards for protection of human research subjects, and to ensure that all data are accurate and reliable.

• An initial site visit, also called a site initiation visit, should occur prior to subject enrollment. The monitor will review the protocol, implementation plan and delegation log with research staff.
• Visits happen on a periodic, reoccurring basis. Monitor visits require research staff to be available to answer questions. Staff do not need to be with the monitor at all times.
• The monitor will let research staff know the frequency of monitoring visits and the percentage of records to be reviewed each visit during the site initiation visit.

IMPORTANT: If the monitor asks a question during the visit and you do not know the answer, find the answer from the appropriate person and report back. It is ok to say that you do not know and will find out the answer.

Core(s): Regulatory Knowledge and Support

• Study Development, Planning, and Design ,
• Study Start-Up ,
• Study Conduct ,
• Study Close-Out ,
• Regulatory and Compliance ,

Site Initiation Visits: Starting Your Trial On Track

Presenting The Protocol The CRA’s task is not only to present the protocol, but to engage the team. The doctors, nurses and pharmacists involved in the study are busy, and making them sit through hundreds of presentation slides may not give the trial the best start. Instead, the CRAs give the team the chance to ask questions, in an interactive session. They answer any questions the PI and other staff have about the study, and address any issues before the trial starts. The presentation might cover the design of the trial, the drug or treatment being tested, and any relevant background information about the therapeutic area, always keeping the audience in mind. Details like eligibility criteria for enrolment, how to store and administer the drug, and quality management points are also included.

The Trial Walk-Through In a meeting with everyone involved, the CRA will lead the group in a walk-through of the study, often from the perspective of a participant. By looking at the process from enrollment to trial end, the CRA can ensure the whole team understands what lies ahead in the trial. They can also identify any gaps in knowledge and spot potential problems before they arise.

Checking Documentation And Equipment The SIV includes some logistical and physical checks. The CRA checks that the drug is on-site, available and correctly stored. They ensure the team has the necessary equipment, such as lab kits or ECG machines, and that those who need access have it. The CRA checks the relevant documentation has been completed, such as regulatory documents, informed consent documents. Finally, they ensure the relevant team members have access to the systems and portals they will use during the trial.

Why Experience Matters

While every study is different, a CRA applies the same skills to make each SIV a success. With experience across a range of trials in different therapeutic areas, a CRA can take the most effective approach to their presentation of the protocol, answer questions about the trial with confidence in their knowledge, and cover all bases to get the trial started in a positive direction.

At Siron Clinical, our CRAs have at least 15 years’ experience in setting up and running clinical trials – including site initiation visits. Find out more about how we can support you .

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Site Qualification Visits and Site Initiation Visits

Thank you to Patient Recruitment Centre: Leicester for providing this content Version 1 - March 2023

Download .pdf version of Checklist here

Site Qualificatio n Visit Checklist

The purpose of a SQV is to assess whether it is feasible for a site to run a study from the sponsor perspective. You will still need an internal feasibility assessment to discuss the study in much more detail, in particular recruitment strategies and targets. 

Consider making a video tour of your facilities since this reduces staff burden and provides an overview of site. It also showcases your research department and can be used during the EOI process. You can find examples of this here . 

Book a room and establish if in person or virtual.

Be prepared to give a tour of your facility including relevant departments e.g. pharmacy.

Ensure you have display screen equipment for SQV slides. If your organisation does not allow encrypted or external devices, request that the slides are sent in advance.

Invite appropriate people from support departments e.g. pharmacy or radiology,  or consider if they will have a separate meeting with the sponsor.

Make sure you can accommodate the number of attendees, internally and from the sponsor and/or the CRO and allow for additional guests. 

Preparation Needed

Ensure your department is clean and tidy and be aware of confidentiality with departmental documents.

Review material provided e.g. protocol synopsis, training slides and compile questions.

Check you have equipment required e.g. fridge, freezer, centrifuge, and space resource. If not, make a list of what is required.

Collate any information about previous sponsor audits or site inspection outcomes.

During the Meeting

Ask the following questions:

 What is the status of the study?

 What are the study timelines?

 What is the expected target?

 What is the recruitment period?

 Number of UK sites?

 Is the protocol finalised? Can amendments be suggested by PI and site staff?

 If the study is already open what have the challenges been?

 What is the screen failure rate?

Identify any equipment that the sponsor will need to provide or fund and who will order them. Ensure this is discussed and clear at an early stage. Do not wait until SIV when the contract will likely have been finalised.

Review recruitment strategy.

 Will they allow PIC sites?

 What support do you need from the sponsor e.g. what advertising materials are provided? Is there the opportunity to suggest alterations?

Ask when the sponsor will inform the site if they have been selected or not.

After the Meeting

Follow up with any actions.

Be prepared to provide documentation such as GCP certificates, CV’s, calibration certificates, FDF, and a contact list of staff.

If you are not selected as a site, remember to ask for feedback.

Site Initiation Visit Checklist

Th e sponsor run the SIV, however the lead site staff can utilise this opportunity to ask any remaining queries regarding the protocol and identify any outstanding requirements.

Ensure you have display screen equipment for SIV slides. If your organisation does not allow encrypted or external devices, request that the slides are sent in advance.

Invite all staff who will be working on the study. If they are not available they can review the slides after the event. Best practice would be to book SIV when all key site staff are available. The PI may only be needed for part of the meeting.

Invite appropriate people from support departments e.g. pharmacy or radiology and consider if they will have a separate meeting with the sponsor.

Make sure you can accommodate the number of attendees internally and from the sponsor/CRO. Be prepared for additional external staff to attend.

Some SIVs can last the full working day. Ensure you are clear on how long the meeting is meant to be and ensure you are aware of lunch arrangements i.e. is the sponsor providing or funding.

Prepare any questions you have about the study beforehand.

Review whether everything is in place for starting the study - IMP,  lab kits, system accesses, all documents including site files, equipment e.g. ECG, medical devices. This may not be the case for some studies with expedited set up.

Ensure you know the protocol.

Ensure someone is in attendance that knows the contract, in case any activities are discussed that are not included in the contract.

Complete the SIV attendance log or send a list of attendees to the CRA.

Circulate the delegation log  if not already completed.

Raise any queries about missing equipment, documents etc.

Review inclusion and exclusion criteria.

Source document review  - Agree what documents are source and what electronic systems the monitors will need access to.

Decide who will be reviewing the safety reports.

Record the SIV training on the finance tracker so it can be invoiced.

Put a plan in place for screening the first participant.

Review the participant recruitment pathway.

Consider a dummy run especially if numerous support departments are involved.

Request any amendments to the contract that are identified.

Make worksheets if not already prepared at this point.

Your session is about to expire

Clinical trial basics: site initiation visit (siv).

What is an SIV in clinical research?

SIV Definition: Site initiation visit

An SIV (clinical trial site initiation visit) is a preliminary inspection between the sponsor and the trial site before the enrollment and screening process begins. It is conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial, from protocol to staff training. [ 1 ][ 2 ]

Also known as a study start-up visit, the sponsor can only request an SIV after the site has been selected and agreements such as the CTA and CDA have been signed.

What is the purpose of an SIV?

Clinical trial SIVs are necessary to ensure that all personnel involved in the clinical trial, such as investigators and study staff, thoroughly understand the trial protocol and are trained to handle their role and responsibilities.

Furthermore, a site initiation visit ensures the trial site is operational-ready with working infrastructure, tools, and materials which helps streamline future efforts such as recruitment. [ 1 ]

Given the scope of the SIV, clinical trial sponsors should schedule this visit well before enrollment so that there is plenty of time to comprehensively inspect all relevant processes.

Can the SIV be conducted before IRB approval?

IRB approval is necessary before an SIV. Clinical trial sponsors need to be sure they have selected a site that has fulfilled all the necessary regulatory requirements and is operating in compliance with IRB guidelines.

SIV checklist for thorough site initiation visits

Given the importance of an SIV, clinical trial sponsors and CROs need to make the most of this inspection visit by coming fully prepared with a detailed checklist that outlines the SIV.

Clinical trial sites should also have a copy of this checklist to ensure all relevant staff is present. Specific tasks to include in the SIV checklist include the following tasks: [ 1 ] [ 2 ][ 3 ][ 4 ]

• Discussing clinical trial objectives with study staff
• Educating the research team on Good Clinical Practices
• Reviewing the operation schedule for the protocol
• Discussing the enrollment and screening process, including clarifying inclusion and exclusion criteria
• Reviewing the informed consent protocol
• Clarifying the procedure of storing and dispensing the investigational drug
• Checking inventory for all medical supplies and equipment
• Ensuring access to all digital platforms, i.e., correct usernames and passwords
• Touring the clinical trial site
• Reviewing and discussing all clinical trials documentation, such as forms, surveys, and manuals
• Reviewing the data management system
• Ensuring clinical trial staff understand how to maintain essential documentation
• Reviewing the financial protocols, including any processes related to compensating trial participants
• Checking reporting systems for possible adverse events
• Discussing specific concerns trial staff may have

This checklist provides the basic guidelines that can be used to build upon to create a complete agenda for an SIV. Clinical trial sponsors can add to these as required per their clinical trial design.

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Ends after successful study initiation

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Ends after the last participant has completed the last study visit

Starts with last study visit completed

Ends after study publication and archiving

Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Preparation

What is it why is it important.

The Site Initiation Visit ( SIV) should be well prepared because it provides an important opportunity to train staff on study tasks and responsibilities .

In most cases, the SIV is performed by the monitor(s) who presents the planned monitoring procedures; while the SP-INV  or a delegate presents the study protocol .

The SP-INV can appoint other personnel to perform the SIV. However, the SP-INV must ensure that those performing the SIV are well-qualified and properly trained to perform this task.

What do I need to do?

As a SP-INV ensure that the monitor performs his or her tasks according to the monitoring plan .

If you are the study monitor, prepare the site for an upcoming SIV:

• Arrange a date for the SIV visit with the site and invite relevant staff
• Prepare an agenda with topics to discuss, including what processes and tasks to train
• Complete pre-study TMF and ISF filing . The ISF is handed over to the site at the SIV
• Ensure that IMP/MD is available at the study site and ready to use
• Confirm access to the study database needed for staff training
• Decide on who will be responsible for any staff training
• Prepare relevant study logs , such as the delegation log and a SIV training log
• Prepare a SD location list. In a multicentre study prepare an applicable list for each participating site

Prepare an easy-to-follow and relevant study presentation:

• Include diagrams or flow-charts. A clever designed image can replace highly complicated written procedures (e.g. the study design, safety reporting , analytical processes)
• A physician / Site-INV  or delegate can present and explain more complicated medical issues
• Make sure that the infrastructure needed for your presentation and training sessions is available at the site (e.g. a beamer, flip chart, video transmission, magnet board, material needed illustrate points)

In order to guarantee effective communication and training, use a local or common language. If needed, organise an interpreter who can participate at the SIV.

Where can I get help?

Your local CTU ↧ can support you with experienced staff regarding this topic

Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch

Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch

Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch

Geneva, Clinical Research Center, CRC, crc.hug.ch

Lausanne, Clinical Research Center, CRC, www.chuv.ch

St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch

Zürich, Clinical Trials Center, CTC, www.usz.ch

External Links

• swissethics – Information on safety reporting
• swissmedic – Information on safety reporting

ICH GCP E6(R2) – see in particular guidelines

• 4.11 Safety reporting
• 5.18 Monitoring activities
• 8. Essential documents for the conduct of a clinical trial

ISO 14155 Medical Device – see in particular section (access liable to costs)

• 9.2.4.4 Initiation of the investigation site
• 10.8 Safety Reporting
• Annex E: Essential clinical investigation documents

ClinO – see in particular article

• Art. 37 – 43 Safety Reporting

HRO – see in particular article

• Art. 20 – 20 Safety notification
• ClinO – Clinical Trials Ordinance
• CTU – Clinical Trials Unit
• GCP – Good Clinical Practice
• ICH GCP – International Council for Harmonisation Good Clinical Practice
• IMD – Investigational Medical Device
• IMP – Investigational Medicinal Product
• ISF – Investigator Site File
• ISO – International Organisation for Standardisation
• SAE – Serious Adverse Event
• SD – Source Data
• SIV – Site Initiation Visit
• Site-INV – Site Investigator
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• TMF – Trial Master File
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Making the Most of Site Training: Lessons from the Pandemic

The investigator meeting and site initiation visit (SIV) are two critical milestones marking the beginning of a clinical trial for members of the site team.

Traditionally, investigator meetings involve the principal investigator and study coordinator traveling to large conference venues or hotels to view multiple presentations over the course of a few days. Often, the investigator meeting falls well in advance of the site’s target date to enroll a patient, and while these meetings are excellent networking and learning opportunities, learnings may be outdated by the time the site initiates. The SIV follows weeks or months later when the clinical research associate (CRA) arrives at the site. The CRA often arrives with a sizable amount of study-related information to disseminate to the site team. This challenging process is replicated by different CRAs across site teams in other regions or countries.

In some cases, PowerPoint is the best option to present information. When used effectively, it’s easy to use, easy to share, and cost-effective. Also, it is good for well-structured and concise presentations that are less than 10 minutes. If a presentation goes longer than 10 minutes, even the best speakers will start to lose impact.

In particular, SIVs do not lend themselves well to the PowerPoint approach because these meetings are lengthy and involve vast amounts of information. The challenge of presenting engaging and impactful information is compounded in a virtual setting.

Additionally, PowerPoint presentations vary widely between presenters and meetings , which potentially introduces misunderstandings and errors before the study begins. A CRA might present the material perfectly, and attendees may absorb all the information completely, but PowerPoint consistency is not likely.

Ensuring the Remote Investigator Meeting or SIV Meeting is Productive and Useful

Now more than ever, organizations prefer to virtually attend meetings rather than travel to a physical location. While some stakeholders may not view virtual formats as ideal, they still must ensure sites are well prepared and educated to enroll patients into clinical trials. Without gathering staff in person for a meeting or observe their engagement, it may be harder to gauge how much they have learned and how likely they will be to retain it. In this remote world, communicating in an uninteresting or disorganized manner can be disastrous.

To maintain an audience’s attention, look at an alternative approach. Try introducing variety to break up the training formats for the different SIV agenda items. For example, animated video is a well-recognized, impactful format and is very well suited in conveying study designs, disease overview , and IP mechanisms of action . Other sections may be better suited for simply reading and acknowledging a document similar to the narrative approach outlined above (e.g., a discussion around recruitment strategy). Additionally, a concise and well-delivered PowerPoint may suffice (e.g., a study introduction from your respected key opinion leader (KOL).

An added benefit of utilizing different training formats for different items means deploying information online through a site study portal for attendees to complete or view beforehand, allowing for shorter online meetings and more practical and audience-friendly interactions.

Since most informational meetings are currently conducted remotely, relying on a blend of video and other appropriate formats is a more productive way to disseminate information.

Using a site study portal to get information out to sites at the trial outset (as well as through the entire duration of study conduct) provides additional benefits. Deploying and tracking material through a validated 21 CFR Part 11 environment supports inspection readiness. And a portal can also provide analytics to assess engagement, and any presentations can be recorded and deployed as training modules for site staff who join the site team later in the study.

Advarra offers the solution to provide these benefits, reduce variability from presentation content, and offer sponsors and CROs the ability to know exactly how well site staff understands critical content and how prepared they are to operate a successful clinical trial.

Tagged in: CRO , longboat , site training , sponsors , training

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Advarra offers the solution to provide these benefits, reduce variability from presentation content, and provides sponsors and CROs the ability to know exactly how well site staff understands critical content and how prepared they are to conduct a successful clinical trial. Learn more about Advarra’s Longboat Platform .

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