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GA-102: Document Development & Change Control

SOP No.: 102   SOP ON SOPS:  DOCUMENT DEVELOPMENT AND CHANGE CONTROL
Author:    Office of Human Research
Effective Date:  October 1, 2007 Supercedes document dated:     N/A
Last Reviewed on:    N/A Results of Review:    N/A
This SOP pertains to:  All SOPs used in FDA-regulated human subject research within Thomas Jefferson University
Responsibility for executing this SOP:  Investigator and Designated Research Personnel
Approved By:
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR)
Approved By:
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR)

1. PURPOSE

This procedure describes the steps to be followed for developing, revising and approving controlled and non-controlled documents for FDA-regulated human subject research documentation regardless of whether an IND or IDE is in place.

2. GENERAL INSTRUCTIONS

The OHR is responsible for reviewing, approving, distributing, rendering obsolete, and archiving all controlled documents; distributing, rendering obsolete, and archiving all non-controlled documents; maintaining an Index of Forms and other documents; and maintaining a Table of Modifications for recording all revisions to existing forms and other documents.

3. SPECIFIC PROCEDURES

3.1 Process Requirements for Specific Documents

  1. The following documents are controlled documents:
    • Clinical protocol (including monitoring plan)
    • Protocol amendments
    • Case report forms (CRF)
    • Informed consent form
    • Investigator Brochure
    • Equivalent medical device study documents (Investigational Plan, Report of Prior Investigations)
    • Adverse event reporting form
    • Certain other FDA documents (consult with OHR)
  2. All other documents that are developed for clinical study purposes are considered non-controlled.

3.2 Document Initiation and Approval Procedures

The Author will use the procedures below for the drafting, review, approval and revision of controlled documents.

  • The OHR will determine which documents are needed for developing regulatory submissions, collecting data or other study information, and/or performing any other study-related function.
  • The OHR will determine who will draft the first version of a given document (the Author).
  • The OHR will jointly determine who must review and approve the first and succeeding drafts in accordance with federal and University guidelines (the number of reviewers is determined case-by-case).
  • The OHR will use templates or other available guidelines for developing new documents where available, and initiate the document drafting process.
  • The OHR will complete the Document Control Form (SOP 102 Attachment A), noting "version date" in the Document Number section and in the Footer of the document.
  • If the controlled document requires additional review, the OHR should circulate the draft, with the Document Control Form as its cover, securing signature/review date, comments and suggestions from all specified reviewers.
  • The OHR will revise document per initial review process, and if any revisions are not incorporated, he/she will notify the affected reviewer(s) of the reason(s) for not including the revision(s), and negotiate a resolution, documenting any significant differences in the space provided on the Document Control Form.
  • The OHR will continue to circulate the revised document to all signatories with the Document Control Form as its cover, until the review process is complete. The document will have a version date for each review and then a final version date.
  • The OHR will ensure all required reviewer approvals are indicated by entries in the Signature and Approval Date boxes of the Document Control Form.
  • Upon final signature of the last reviewer, the OHR should sign and date the Document Control Form in the space provided to indicate responsibility for that document.
  • Following final approval, the OHR will assign all newly approved documents a version number (-00) and effective date.
  • The OHR will retain the original approved document and Document Control Form(s) in the appropriate archive file or section of the Regulatory Master File.
  • The OHR also will update any related indices (e.g., List of Forms) to include the new document.
  • For new, non-controlled documents, there are no specific required procedures to follow to develop those documents, but the OHR must approve the development of new documents and their final version.

3.3 Document Change Procedures

3.3.1 Review of Controlled Documents

  • The OHR will review controlled documents periodically or as needed by circumstances (e.g., new federal or state regulation, new University or institutional policy or procedure, or need for update of Investigational Brochure, etc).
  • Revision of Controlled Documents if revisions are needed in a controlled document, the OHR will do the following:
    • Have the Author of the change(s) circulate the revised draft with a copy of the original, clearly noting the changes, using the Document Control Form as its cover
    • Continue to give updated and revised controlled documents a new version number (-01, 02, etc.) and a current effective date
    • Document periodic review and updating by maintaining an accurate Table of Modifications Form for each controlled document (See SOP 101 Attachment C)
    • Mark prior version of the controlled document "Obsolete" and save copy for the appropriate archive file or section of the Regulatory Master File
    • Update any related tables or indices, as appropriate (refer to the current OHR policy for details)

3.3.2 Revision of Non-Controlled Documents

When revisions are needed in a non-controlled document, the Author of the non-controlled document or a designee will do the following:

  • Make the change(s) and circulate the revised draft with a copy of the original, clearly noting the changes and why they are needed.
  • Continue to give updated and revised non-controlled documents a new version number (-01, 02, etc.) and current effective date.
  • Document periodic modifications of non-controlled documents by maintaining an accurate Table of Modifications Form (See SOP 101 Attachment C).
  • Mark prior version of the document "Obsolete" and save copy for the appropriate archive file (see specific SOP for location).
  • Update any related tables or indices, as appropriate (e.g., List of Forms).

3.4 Document Implementation Procedures

  • The Investigator will ensure that all appropriate staff are trained in the proper use of the new or revised document. 
  • The Investigator will make a list of all affected parties and appropriate regulatory authorities (IRB, FDA) who must be notified of changes to applicable documents and notify them in writing when the changes are implemented (or prior to implementing, if appropriate).
  • The OHR will provide the updated version of appropriate documents to affected parties.

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 312.53 Selecting investigators and monitors
21 CFR 312.60 General responsibilities of investigators
21 CFR 312.61 Control of the investigational drug
21 CFR 312.62 Investigator recordkeeping and record retention
21 CFR 312.64 Investigator reports
21 CFR 312.66 Assurance of IRB review
21 CFR 312.68 Inspection of investigator's records and reports
21 CFR 312.69 Handling of controlled substances
21 CFR 54 Financial Disclosure by Clinical Investigators
January 1988 Guidelines for the Monitoring of Clinical Investigations
FDA Information Sheets October 1998 Frequently Asked Questions, Continuing Review After Study Approval, Recruiting Study Subjects, Payment to Research Subjects, Screening Tests Prior to Study Enrollment, A Guide to Informed Consent, Investigator-IRB Interrelationship
May 1997 International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline

5. REFERENCES TO OTHER APPLICABLE SOPs

All SOPs are applicable to this SOP.

6. ATTACHMENTS

7. DEFINITIONS

The following definitions from the International Conference on Harmonisation, Good Clinical Practice: Consolidated Guideline apply to this SOP.

Clinical trial/study: Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Subinvestigator: Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows)