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