The NINDS has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in NINDS-supported clinical trials. Therefore, prior to subject accrual, the Awardee will provide the following for review and approval by the NINDS:
- The detailed plan for data and safety monitoring (see Section B below).
- The clinical research protocol, including details of study design, proposed interventions, patient eligibility and exclusion criteria, plans for the management of side effects, procedures for assessing and reporting adverse events, and data analysis plans. Refer to the protocol template.
- In studies where a pharmaceutical/biotechnology company is providing the study agent/device, a written agreement by a company official affirming this arrangement.
Within 30 days of receipt of all of these documents, NINDS staff will review the study documentation and inform the Awardee in writing of any remaining issues that need to be resolved. In some cases, the NINDS will send a team of site visitors to the PI's site to help ensure that the study is ready to proceed.
- Data and Safety Monitoring Requirements
Independent monitoring of interim data is strongly recommended for all clinical trials. A final data monitoring plan must be agreed upon by the Awardee and the NINDS before study enrollment commences. For further information, refer to the NINDS Guidelines for Data and Safety Monitoring in Clinical Trials.
- Use of NINDS Common Data Elements (CDEs)
- Changes in Protocol Design and Status
- Amendments to the protocol
- Termination of the protocol
- Temporary suspension of the protocol
- Changes in informed consent or IRB/EC approval status
- Temporary suspension or permanent termination of patient accrual
- Other problems or issues that could affect the human subjects in the studies
Funding support recommended for each year of the project is only an estimate and is contingent upon favorable review by NINDS staff of the progress of the project, sufficient subject accrual, and demonstrated need for the funds. Funds awarded for patient care costs may not be used for any other purpose without the prior written approval of the NINDS.
- Clinicaltrials.gov Registration and Results Reporting
ClinicalTrials.gov is a database of federally and privately supported research trials to test the effect of treatments and procedures for a wide range of diseases and conditions. The NIH is committed to providing information to increase public awareness and access to clinical trials sponsored federally and by industry and foundations. Awardee is required to comply with Public Law 110-85 (Food and Drug Amendments Act of 2007: FDAAA), as applicable, for required clinical trial registration and results reporting.
This award provides support for one or more clinical trials. NINDS is not the sponsor of any applicable clinical trial conducted under this award.
By law (Title VIII, Section 801 of Public Law 110-85), the “responsible party” must register Phase II-IV “applicable clinical trials” on the Clinicaltrials.gov website. Applicable clinical trials must be registered no later than 21 days after the first participant is enrolled. "Basic results" information for applicable clinical trials is to be submitted within one year after the “Primary Completion Date” of the trial.
- Other Required Reporting During the Award Period
Awardees are required to notify the NINDS of any of the following circumstances:
- A change in the membership or operating procedures of any external advisory committees, including Safety Monitoring Committee (SMC), or a change of the Medical Monitor. The CV of any new Study Monitoring Committee (SMC) member or Medical Monitor must be submitted to the NINDS thirty (30) days in advance of the anticipated change.