The ICH GCP Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data produced. These documents serve to demonstrate compliance with standards of Good Clinical Practice and with all applicable regulatory requirements. Filing essential documents in a timely manner can greatly assist in the successful management of a clinical trial.
The Regulatory Binder is often the first document reviewed during audits and inspections. Not all the essential documents are available at the start of the study. Documents can be grouped into those that are generated before study initiation, those that are generated during trial conduct and those that are generated after study completion.
Not all documents have to be filed in one single binder. The Regulatory Binder may sometimes consist of several binders that are stored in the same or different locations. It is important to know where all these documents are located to be able to pull them out when needed in a timely manner. The Regulatory Binder is referred to synonymously as the Study Files, Investigator Files or Investigator Binder.
Organizing Your Regulatory Binder
Create tabs for each section listed below and place the appropriate documents in each corresponding section in a binder. Be sure to label the outside of the binder (cover and spine) with the protocol number, PI name, and study site. Use multiple binders or master binders to maintain documentation if needed. A sample Regulatory Binder Table of Contents is provided for your convenience. All sections are required unless otherwise indicated.
|The Monitoring Log provides documentation at the site that the study was monitored and the frequency of monitoring. The monitor and designated site staff both sign the log to verify the date the monitor was present. For consecutive days, each day is entered separately.|
|The Delegation of Authority Log documents responsibilities assigned to research team members and their dates of involvement in the project. It helps ensure the appropriate delegation of study related tasks.|
|The Site Personnel Signature Log documents the names and provides handwriting samples of all personnel involved in the conduct of the study|
|All personnel involved in research with human subjects are required to complete the following:|
CITI Course in the Protection of Human Research Subjects
When adding personnel to the study, they must complete all of the above and their addition must be IRB approved prior to participating in the study.
|The Training Log is a record of training provided, e.g. protocol training or other study-specific training of staff. This should include a site initiation visit (SIV) attendance log.|
This section should include:
Note: Any time information is kept in a master binder, place a note to file (in the section of the Binder) referencing the location of the separate binder.
All research studies that meet the definition of a clinical trial must be publicly registered as per the International Committee of Medical Journal Editors (ICMJE), the FDA Amendment Act of 2007, and Health System policy.
Contact the UCSF PRS Administrator, Marlene Berro at firstname.lastname@example.org to set up a Clinical Trials. Gov PRS user account. Note: For commercially funded, multi-center studies, public registration is typically handled by the study sponsor or CRO. Place the registration receipt in this section for initial registration and for any updates.
|The Screening/Enrollment Log should include a log of subjects who were screened (and reason for screen failure) and enrolled. Some studies allow for re-screening of subjects.|
|The Subject Visit Tracking Log tracks all enrolled subjects' visits, reason for early termination and keeps visits scheduled as per protocol.|
|The Consent Forms section should include consent form document(s) (all IRB approved and stamped versions) stored in reverse chronological order with the current approved version first. Place the most currently approved consent form in a plastic sleeve Note: Any changes to the consent form must be submitted to and approved by the IRB prior to use. Recommendations for consent of Non-English speaking subjects can be found within the HRPP Consent Guidance.|
|The HIPAA Forms section includes all IRB approved and stamped versions of any of the HIPAA forms (as applicable).|
|The Protocol Template should include the protocol (and protocol signature page) and all amendments (and amendment signature page or pages), stored in reverse chronological order with the current approved version first. Any changes to the protocol must be submitted to and approved by the IRB prior to implementation.|
|The IRB Federal Wide Assurance Letter should contain the most current IRB assurance letter.|
|This section should include copies of the original IRB application/submission, IRB approval letters (contingent and final approval), and all correspondence with the IRB (including emails). It includes IRB Membership Rosters, Continuation Review Submissions, protocol modifications and DSMB reports and close-out (final study) reports.|
|If your research study is being terminated or if the PI is leaving and the study will no longer be continued, complete and submit an IRB Termination Report to the IRB.|
|The Protocol Deviations / Protocol Exceptions section should include correspondence relevant to the issue and copies of the documents stored in reverse chronological order with the most current documents first. Certain Sponsor-approved waivers may need to be approved by the IRB prior to implementation.|
|The Serious Adverse Events section should include correspondence, copies and acknowledgements of reports for internal SAEs reported to the IRB and Sponsor and FDA as applicable. Use an AE/SAE log for each subject enrolled in studies that involve drug intervention. Unanticipated Problem Log (let's enclose this link into a sentence)|
|The IND Safety Reports section should include correspondence (including IRB acknowledgement) and copies of Safety Reports for external SAE reported to the IRB. .|
|Advertising/Educational Materials (if applicable)|
The Advertising/Educational Materials section should include: Any IRB approved advertisements, recruitment flyers, written educational, or other materials provided to study participants, stored in reverse chronological order with the most current documents first. Marketing materials used to recruit through mass media (e.g. newspaper, TV, radio, some internet postings, & etc.) must be approved by the UCSF Communications Office to ensure logo/branding is appropriate.
|The Sample Tracking and Shipping section should include a master log that allows tracking of research specimen sample collection, shipment (or transport), and storage, and packing and shipping training certification. Shippers or receipts can be placed in this section or in individual subject files. All biological materials must be handled, storedand shipped in compliance with FAA and IATA regulations as well as UCSF policies on hazardous materials.|
|Refrigerator/Freezer Temperature Logs must be kept in compliance with Protocol /Study Procedures requirements and GCP.|
For every lab listed on FDA Form 1572, place a copy of (maintain current certifications for duration of study):
Note: The above is not required for research labs that perform testing where results will not be shared with subjects or their treatment providers.
|Please document and maintain all relevant, significant communication from the sponsor, the CRO or monitor in this section. Study related Newsletters may be placed in this section.|
|Include a blank CRF in your Regulatory Binder.|
|The Notes To File may include site generated and/or sponsor generated notes to file. Sponsor generated NTF may be global or site specific.|
|The Record Retention Matrix contains retention guidance and disposition requirements for administrative records relating to research.|
Place other important study documents in this section. This can include:
Additional Tools are available for your convenience.
We would like to hear from you. If you have suggestions, comments, or questions about the regulatory binder, please contact:
Marlene Berro at email@example.com or at 415-476-9429
Last updated 31 Dec 2012