- 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
Protocol Templates
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.
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.
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.
Protocol Associated Documents
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.
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.
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 Documents and Associated Case Report Forms
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.
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.
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.
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.
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
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.
This document provides a log template for tracking all protocol deviations/violations across a study.
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.
This document provides a log template for tracking all adverse events (AEs), including serious adverse events (SAEs), across a study.
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
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.
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.
This document provides a log template for recording the daily temperatures for investigational product (IP).
This document provides a log template for capturing all investigational product (IP) dispensed to and returned by participants for the duration of the study.
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
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.
This document provides a log template for chronologically documenting the participants who have been enrolled in the study.
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.
This document provides a sample form template for documenting the informed consent process.
Additional Participant Tracking Logs and Materials
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.
This document provides a log template for tracking the collection and storage of research samples.
Staff Training and Administrative Tracking Logs and Materials
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.
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.).
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.
This document is typically completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.
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.
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.
