Regulatory documents in clinical research

Regulatory documents in clinical research

1. Regulatory Documents in Clinical Research

2. 1572 - The Investigator’s Agreement This document holds the Principal Investigator responsible for the overall conduct of the study at their site The 1572 will cover: Name and address of PI and site/facilities Name and address of labs Name and address of IRB Names of Sub-Investigators and Coordinators Name and description of study protocol

3. Financial Disclosure Forms A signed Financial Disclosure Form (FDF) is required for every person included as a PI, Sub-I, or Coordinator on the 1572 This form declares that the person signing it has no financial interest in the pharmaceutical company conducting the study

4. Protocol and Signature Page PI must sign most recent version and train staff Site must send signature page to Sponsor and IRB

5. Delegation Log This document lists who is responsible for each task in conducting the study The PI must sign this log to delegate these tasks to Sub-Is, Coordinators, and other site staff and indicate the start/stop dates for each person in the study. Each person must have adequate training and/or credentials in order to be delegated any tasks

6. Credentials Site must ensure that the following documents are filed for every person on listed on the delegation log: CVs - Must be current and signed GCP certificates - Every single staff member must have GCP training IATA certificate - Required for anyone who will be shipping specimen Study specific training certificates - This may include EDC training Medical licenses - Required for doctors, nurses, and medical staff Make sure that all documents are up to date and not expired

7. Training Log Any person on the Delegation Log must have documentation of training This will include topics such as: protocol and amendments, informed consent, etc. Could be self-trained, trained by PI/Sub-I/Coordinator, or trained by the monitor All staff must be retrained with every new protocol amendment

8. IRB Approvals Every year, sites must apply to renew IRB approval and forms must be filed Initial and continuing reviews all need to be filed Site is also responsible for filing any and all IRB approvals for anything relevant to the study, such as protocols, ICFs, marketing material, etc.

9. Patient Identification, Screening and Enrollment Log Sites must maintain an up to date log that lists each subject’s: Assigned subject ID Name and initials Date of birth Date of consent Version/amendment signed

10. Investigational Product Logs Sites must file: IP order forms Shipping documents to confirm receipt A log of kits received and dispensed (accountability log) Packing slips

11. Safety Reports Sites must file SUSAR (Suspected unsuspected serious adverse reaction) reports These reports are published and distributed by the sponsor and IRB when SAEs are reported Some SAEs will qualify to be reported as a SUSAR Certain criteria need to be met in order to qualify as a SUSAR

12. Newsletters and Correspondence IRB, CRO, Monitor and Sponsor correspondence need to be filed Correspondence can be in the form of printed emails or formal letters to and from the sponsor or CRO Confirmation and Follow up letters need to be filed for every monitor visit Monitor visit logs also need to be filed and updated at every visit Sponsor issued newsletters also need to be filed

13. CLIA Waiver Every site needs to have a CLIA waiver filed for operating a lab and processing specimen Although most sites use central laboratories, a CLIA waiver is still required because blood is drawn and shipped from the site

14. Investigator’s Brochure An investigator’s brochure is a document that contains all the known data pertaining to the study drug, and must be filed This document rarely ever gets amended Also needs to be signed/acknowledged by the PI