The clinical trials electronic protocol writing template/tool provides a useful format for NIH-funded Phase II and III clinical trials that are being conducted under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. The goal of the template is to help investigators think through the scientific basis of their assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data. A common protocol structure and organization will also facilitate review by oversight entities. The template is modifiable to any type of clinical trial, including clinical trials with behavioral interventions, and is available as an online collaborative tool or as a Word template.
Protocols and other materials (such as IND/IDE application and manufacturer's product specifications) should NOT be included in the application. These documents are only allowed when specified/required in the funding opportunity.
For NIDCD U01 Applications
A clinical trial protocol is not required or allowed as an attachment for the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) PAR-24-050 application package; however,
- If the intervention is a drug, biologic, or device, the application package must contain confirmation of the FDA’s review of the study protocol as well as documentation of the FDA’s feedback of the study protocol [Section 4.5 FDA Documentation].
- Since a full clinical trial protocol and informed consent will be required and subject to review and acceptance by NIDCD at the time of funding, investigators should plan ahead and utilize the Clinical Trial Protocol Template for Phase II and III IND/IDE studies (as developed by the FDA and NIH) for the protocol document submitted to the FDA and IRB. See Section VI.2: Award Administration Information - Cooperative Agreement Terms and Conditions of Award of the funding opportunity for details.
For NIDCD-Funded U01 Clinical Trials
- The ethical conduct of clinical trials involving human participants starts with the development of a well-designed clinical trial protocol and continues through to the timely and successful completion of a high-quality clinical trial that is scientifically valid and can inform future clinical practice.
- In accordance with the U01 Notice of Award (NGA), the Principal Investigator (PI) is responsible for preparing the protocol and other study related documents for clinical trials supported by NIDCD (only one clinical trial may be proposed per application). The Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies developed by the FDA and NIH should be used (NOT-OD-17-064) to prepare the protocol. The full completed clinical trial protocol and informed consent will be subject to review and acceptance by NIDCD. Activities not related to the scope of the NIDCD funded project should not be included in the protocol.
- In addition to the details specified within each section of the Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies developed by the FDA and NIH, NIDCD U01 protocols must also include the following details:
- Statistical sections must be written by the study team statistician.
- Below the Schedule of Activities table, include a section that describes the components of each type of visit as well as how they are conducted, e.g., face-to-face vs phone call.
- The Efficacy Assessment section must include a description/components of each evaluation as well as interpretation of results, e.g., severity scale.
- The Adverse Event Reporting section must also include the reporting timeline to NIDCD.
- If applicable, address prior FDA comments.
- For drug and biologic study interventions, a Clinical Management section needs to be included. This section provides guidance on how to handle adverse events (AE) potentially induced by the drug/biologic based on the package insert/investigator’s brochure to include but not limited to Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Overdosage, and Patient Counseling Information, e.g., detailed clinical management instructions based on Severity/Grade of AE. This provides clinical management consistency across study clinicians. [Contact the NIDCD Medical Officer to request an example template.]
- Include a statement that participant safety overrides protocol: It is understood that treating physicians will provide whatever available treatment is considered best to protect participant safety and well-being; compliance with study requirements must not compromise such treatment.
- For Devices, include sections describing Post-Trial Transition Plan, Surgical Implantation, Device Components and Specs (implanted components, software, hardware).
- Ensure the NIH Policy on Sex as a Biological Variable is addressed in the protocol.
- Protocol Version and Date Number must be included and updated accordingly.
The Steps Prior to the Implementation of NIDCD U01 Clinical Trials webpage provides information to help you understand the tasks, NIDCD/FDA/IRB/DSMB review timelines, and completion targets related to protocol development.