Can be used to document unexpected problems and report to the study sponsor (NCCIH) and the IRB. This document contains the necessary and additional elements of the authorization form provided by the federal by-law code. The NCCIH Clinical Research Toolbox provides a web-based repository of information for researchers and collaborators involved in NCCIH-funded clinical research. The toolkit contains models, forms and information materials to help clinical researchers develop and conduct high-quality clinical studies. Several essential documents must be organized and retained for clinical trials. These documents are called “Regulatory Binder,” which is kept on the investigator`s clinical site. Customizable Models You Can Use If Needed: Study Identification Essential Documents Location Log Communications Log IRB Suivi Log Deviation/Exception Submission Log Deviation Log-COVID 19 Disruption (NEW) DSMP Template Screening/Enrollment Log Participant Identification Se log Study Participant/Termination Log Internal AE/UP Report Tracking Log (MS) Internal AE /Report UP Tracking Tracking Log (MS Excel) Safety Report Tracking Log (MS Word) Safety Report Tracking Log (MS Excel) Site Visit Log Telephone Call Abstract Report Study-linked REPORT SOPs Task Delegation/Signature Log Staff Training Log Staff Training Log Log for Groups Staff License/Certification Logd Log Journal Journal Article Question Article and/or Return to Sponsor Trial you found this site. I intend to do this to you because you have a productive interest in health information and resource exchange…. Provides a recommended structure for a data and security monitoring plan. Contains tables of text, instructions and sample data, as well as a report template. If NCCIH requires the study researchers to provide a final protocol document, the protocol must be forwarded to the NCCIH program director before implementation is carried out using one of the protocols cited below.
(Note: if the clinical trial is conducted on an institution that has a clinical and translational science award (CTSA), researchers may be required to establish a protocol established by their CTSA. Independent Oversight Committee (ICT) report model [Model 314 KB Word] Used to document the entire position and responsibility of the product for site-level study products. Provides a reference at a glance for the inclusion of important documents for clinical research in a regulatory binder.