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GA 101: Preparation & Maintenance

SOP No.: 101    SOP ON SOPS:  PREPARATION AND MAINTENANCE
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 necessary steps for developing, revising and maintaining standard operating procedures (SOPs) for Food and Drug Administration (FDA)-regulated human subject research regardless of whether an IND or IDE is in place.

2. GENERAL INSTRUCTIONS

FDA Regulations require that all FDA-regulated human subject research be conducted under written procedures. This is interpreted to mean standard operating procedures.

  1. Thomas Jefferson University personnel engaged in FDA-regulated human subject research are responsible for adherence to this SOP to ensure uniform practices.
  2. The Associate Vice-President for Research in the Office of Human Research is responsible for reviewing and approving SOPs with the final approval resting with the Vice-President for Research.
  3. When an Investigator follows Thomas Jefferson University’s approved SOPs for Good Clinical Practices (GCPs), the OHR acts as designee for SOP maintenance and management.
  4. When the Department/Division creates SOPs separate from or in addition to Thomas Jefferson University’s approved SOPs for Good Clinical Practices, the Department/Division is responsible for obtaining approval of such SOPs from the OHR.
  5. The Investigator is responsible for staff knowledge and training on all applicable SOPs.

3. SPECIFIC PROCEDURES

3.1 SOP Initiation and Approval Procedures

FDA Regulations require that all FDA-regulated human subject research be conducted under written procedures. This is interpreted to mean standard operating procedures.

  • The Office of Human Research will determine the need for any additional specific SOP’s (within the framework of Thomas Jefferson University’s SOP Manual).
  • An individual will be designated to write the draft (the Author).
  • The OHR and the Author will also determine who outside of the OHR must review and approve the first and succeeding drafts.
  • The Author will use the SOP Template to format the SOP and initiate the SOP drafting process (See SOP 101 Attachment A).
  • The Author will complete the SOP control Form, noting "Draft 1" in the SOP Number section, and include the Draft number in the Footer of the SOP (See SOP 101 Attachment B).
  • The Author will then circulate the draft, with the SOP Control Form as its cover, securing signature/review date, comments and suggestions from all relevant parties.
  • The Author will revise the draft SOP 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 revisions and negotiate a resolution, documenting any significant differences in the space provided on the SOP Control Form.
  • The Author will continue to circulate the revised SOP to all signatories, with the SOP Control Form as its cover, until the review process is complete. The SOP number section and footer should state "Draft 2" or "Final Draft" or other appropriate designation.
  • The Author will ensure all required reviewer approvals are indicated by entries in the Signature and Approval Date boxes of the SOP Control Form.
  • Upon final signature of the last reviewer, the Author should sign and date the SOP Control Form and the new SOP in the spaces provided to indicate responsibility for that document.
  • The Author will also obtain the appropriate signatories in the OHR as concurrence with the final SOP, in the spaces provided.
  • Following final approval, he/she will assign all newly approved SOPs a version number (-00) and effective date.
  • The OHR will retain the original approved SOP and SOP Control Form(s) separate from or, in addition to TJU’s SOPs for Good Clinical Practices in the appropriate SOP archive file.
  • For TJU’s approved SOPs; the OHR will retain the original approved SOPs.
  • The OHR will ensure that any related indices are updated.

3.2 SOP Change Procedures

  • The OHR will review SOPs periodically, but not less than once every two years, or as needed by circumstances (e.g., new federal or state regulation, new institutional policy or procedure).
  • If no revisions are needed, the OHR will indicate this on the SOP Control Form by checking the Periodic Review box, writing "No Revision Needed" in the Additional Comments section, then sign and date the form.
  • If revisions are needed, the OHR will have the Author of the change(s) circulate the revised SOP draft to the SOP review team noted on the SOP Control Form, with a copy of the original, clearly noting the proposed changes, and using the SOP Control Form as the cover of the circulated document.
  • When SOPs are reviewed, a designee will provide a review date and results of review. When SOPs are edited or revised, the designee will provide a new version number (e.g., -01, -02, etc.) and current effective date.
  • The OHR will document periodic review and updating of SOPs by maintaining an accurate Table of Modifications Form for each SOP (See SOP 101 Attachment C).
  • A designee in the OHR will mark the prior version of the SOP "Obsolete" and save a copy for the appropriate SOP archive file.
  • The OHR will update any related tables or indices, as appropriate (e.g., List of SOPs).

3.3 SOP Implementation Procedures

  • The Investigator will ensure all appropriate personnel are trained in the proper use of the new (or revised) SOP. 
  • All affected parties will be notified of changes in writing when the new/revised SOP is implemented, or prior to implementation, if appropriate.
  • The OHR will provide updated versions of appropriate SOPs to affected parties.
  • The OHR will initiate collection of all outdated versions of SOPs for disposal, retaining one copy for the SOP archive file.

3.4 Process Requirements

The Author will follow these steps for SOP formatting:

  • Write each SOP according to the SOP Template (See SOP 101 Attachment A), with some modification in format permitted, if appropriate, to add additional sections which may include, for example, Materials or Acceptance Criteria.
  • Assign SOP number and page numbers to all pages of the SOP in the footer.
  • Use the header format displayed in the SOP Template, and include the header only on the first page of the SOP.
  • Outline the SOP according to the decimal system and standard formatting in all sections.
  • Include forms used in the implementation of an SOP as attachments and list in the Attachments section of the SOP.
  • The development, approval and revision of forms that are SOP attachments will follow the procedure in SOP 102, Document Development and Change Control.

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 312.60 General responsibilities of investigators
May 1997 International Conference on Harmonisation; Good Clinical Practice:  Consolidated Guideline
January 1988 Guidelines for the Monitoring of Clinical Investigations
September 1993 FDA Compliance Program Guidance Manual 7348.811: Clinical Investigators

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.

Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.