Regulatory and Compliance

Investigator's Brochure (IB)

• To document that relevant and current scientific information about the investigational product has been provided to the investigator
• Typically there is a signature page in the IB that should be signed by the Principal Investigator (PI) and returned to the study sponsor
• A copy of the IB signature page should be retained
• When updated IBs are issued, they should be filed accordingly. Outdated IBs should not be removed from the file

FDA Form 1572

• To document the agreement of the investigator to provide certain information to the sponsor and to assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic

Financial Disclosure Form (FDF)

• To document the financial agreement between investigator/institution and the trial sponsor
• A FDF must be completed and signed by each investigator. The original must be returned to the study sponsor and a copy retained
• A new FDF must be completed any time there is a change in the investigator's financial situation (i.e. stock purchases, etc.)
• Everyone listed on the 1572 must have a FDF on file

 Master Clinical Trial Agreement (MCTA)

• To document agreements between the PI/institution and the study sponsor and/or CRO

IRB Approval

• To document that the trial has been subject to IRB review approval

IRB Roster

• To document that the IRB is constituted in agreement with Good Clinical Practice
• The Federalwide Assurance (FWA) number can be provided in lieu of an IRB roster

IRB Correspondence

• To document all correspondence between the study site and IRB.
• This should include all email correspondence.

Protocol and Amendments

• Typically there is a signature page in the protocol/amendment that should be signed by the Principal Investigator (PI) and returned to the study sponsor
• A copy of the protocol/amendment signature page should be retained
• When amendments are issued, they should be filed accordingly. Outdated protocols should not be removed from the file

Information Given to a Study Participant

Informed Consent

• To document the informed consent process
• This document must be approved by the IRB before it can be used
• Utilize an informed consent process note to ensure all procedures were conducted during the informed consent process

Other written material 

• Any patient facing material must be approved by the IRB before distribution
• Examples include: patient diaries (electronic screenshots should be submitted), informational pamplets, drug preparation instructions, etc.)

Recruitment Advertisement

• To document that recruitment measures are appropriate and not coercive
• This document must be approved by the IRB before it can be used

Curriculum Vitae (CV)

• To document qualifications and eligibility to conduct trial and/or provide medical supervision of study participants
• Required for each investigator participating in the research study
• CVs must be current and updated every two years, indicate the investigator's association with the institution where the research study is being conducted, and display the address noted on the 1572 (when applicable)
• TIP: It's good to keep a master file of investigator CVs so they are available for all studies. This works for medical licenses as well as lab certifications. If you choose to save your CVs, medical licensures, etc. in one central location, you can make a note to file (NTF) stating the location of the documents to place in your regulatory binder as long as the files are accessible to the monitor and auditors during visits.

Medical Licensure

• To document qualifications and eligibility to conduct trial and/or provide medical supervision of study participants
• Required for each investigator who is a medical doctor participating in the research study
• All licenses must be current
• Expired licenses should not be removed from the file

Delegation of Responsibilities Log/Delegation of Authority Log

• To document the investigator's delegation of certain responsibilities to study personnel in order to conduct the clinical trial.

Training Records

• To document that study personnel have received adequate study-specific training in order to execute the protocol.
• The training record should reflect appropriate training for all study personnel.
• This can include training on specimen collection, handling, and storage.

Laboratory Certification or Accreditation

• To document competence of facility to perform required tests and to support the reliability of results
• Many sponsors require both CAP and CLIA certification
• Certifications must be current
• Expired certifications should not be removed from the file

Laboratory Normal Values

• To document normal values and/or ranges of the tests

Monitor Visit Reports

• To document the completed activities and to address any issues noted during a monitor visit.
• Site Selection Visit (Pre-Trial Monitoring) Report
• Site Initiation Report or Investigator Meeting attendance record
• interim monitoring Visit Reports
• Close-out Visit Report

Sponsor Correspondence

• To document all correspondence between the study site and sponsor/CRO.
• This should include all email correspondence.

Miscellaneous Documentation

• Instructions for handling investigational product and trial-related materials
• Shipping records for investigational products and trial-related materials
• Decoding procedures for blinded trials
• Source Documents-To document the existence of the subject and substantiate integrity of trial data collected. See data management section for more information
• Notification of Serious Adverse Events by Investigator to Sponsor-Notification by originating investigator to sponsor of Serious Adverse Events and related reports. See AE/SAE reporting for more information
• Notification of Serious Adverse Events by Sponsor to Regulatory Authorities
• Notification by sponsor and/or investigator to regulatory authorities and IRB of unexpected Serious Adverse Events. See section on SAEs for more information.
• Subject Screening Log-To document identification of subjects who entered pre-trial screening
• Subject Identification Log-To document that investigator/institution keeps a confidential list of names of all subjects. Allows investigator/institution to reveal identity of any subject
• Subject Enrollment Log-To document chronological enrollment of subjects by trial number
• Signature Sheet-To document signatures and initials of all personnel participating in the research study
• Investigational Product Accountability Log-To document that investigational products have been used according to the protocol. Investigational drug services will have this on file
• Documentation of Investigational Drug Destruction-To document destruction of unused investigational products by sponsor or at site