DUMC Ophthalmology Clinical Research

Standard Operating Procedure: 2.1 Title: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs) AUTHOR Names: Laura Denton Title: Site-Based Research Lead Coordinator Department: Duke University Medical Center - Ophthalmology Signature and Date: Laura Denton 3/11/2008 Effective Date: 3/11/2008 Supersedes: N/A

APPROVED BY Name: Title: Department: Signature and Date: REVISIONS No.

SITE BASED RESEARCH GROUP (SBRG) Karl G. Csaky, MD Medical Director, Site Based Research Group DUMC - Ophthalmology Karl Csaky 3/11/2008

Section

Pages

Initials/Date

ANNUAL SOP REVIEWS Initials/Date Initials/Date Initials/Date Initials/Date

PURPOSE: To describe the procedures by which Standard Operating Procedures (SOPs) for DUMC Ophthalmology Clinical Research are prepared, issued, and revised. To provide a tool for training new personnel in the procedures by which specific activities will be performed at DUMC Ophthalmology Clinical Research. To provide an avenue for identification of new areas where SOPs may be helpful.

SCOPE: Applies to all SOPs for DUMC Ophthalmology Clinical Research. PERSONNEL RESPONSIBLE: The Site-Based Research Lead Coordinator will develop drafts and revisions of SOPs with input from corresponding faculty and staff. The SBR Executive Committee will review and final sign-off will come from the Medical Director of the SBRG. DEFINITIONS: N/A PROCEDURES: The Site-Based Research Lead Coordinator will develop drafts and revisions of SOPs with input from corresponding faculty and staff. The Site Based Research Group (SBRG) will provide regular feedback and input for existing and potential SOPs. All SOPs will include: 1. Brief, informative title. 2. An SOP number. 3. Effective date of the SOP. 4. Dated approval signatures for the SOPs Author and the SBRG Medical Director. Each signature must be a separate individual. 5. Revision history, including date of last review. 6. Purpose of the SOP (i.e., why is this SOP being written). 7. Scope of the SOP (i.e., a statement which describes the personnel, projects, and situations to which the SOP applies). 8. Personnel Responsible for carrying out the SOP. 9. Definitions of items within the SOP to act as a glossary of terms. 10. Description of the procedure (i.e., a detailed description of all tasks to be conducted under the SOP, including when they are to be accomplished, where, and by whom). If an abbreviation is associated with a term, it should be placed in parentheses following the word the first time it is listed. If specific forms or equipment are to be used, they should be specified. Copies of the applicable forms should be attached to the SOP. 11. Resources associated with the SOP. 12. Tools that might help to carry out the procedures within the SOP.

Review and Approval of SOPs 1. The draft SOP will be circulated to, or created by, the Lead Research Coordinator for input. The SOP draft will then go to the SBR Executive Committee. 2. After completing its review, the SBR Executive Committee will reconcile all questions and/or suggested revisions prior to issue. 3. The final version of each SOP must be approved by the SBRG Medical Director before issuance. The Lead Study Coordinator will obtain original or electronic signatures on the SOP cover sheet before releasing the final versions of an SOP. No two signatures may be by the same person.

Distribution of SOPs 1. Each clinic study coordinator will maintain an active SOP manual containing authorized copies of all currently approved SOPs. SOPs will also be distributed to other Eye Center personnel or faculty as appropriate.

Maintaining Original, Signed SOPs 1. The Lead Study Coordinator will maintain a complete collection of current DUMC Ophthalmology Clinical Research SOPs and will retain all obsolete, discontinued, or otherwise superseded SOPs in an SOP archive.

Revision of SOPs 1. SOPs requiring permanent modifications will be revised by the Author or individuals designated by the SBR Executive Committee. Revised SOPs will be circulated for review and approval as described above. 2. The Lead Study Coordinator will update the cover page of the revised SOP to show subsequent revisions of the SOP.

Periodic Review of SOPs 1. All SOPs will be reviewed on an annual basis by the Lead Study Coordinator to determine whether modifications are needed or if the SOP remains in use. If changes are deemed necessary, they will be routed to the SBR Executive Committee for review and approval. 2. If a procedure is no longer in use, the SOP will be considered inactive and stored by SBRG in the SOP archives. 3. Changes to the SOP will be made according to procedures described above. 4. Documentation of annual SOP review will be maintained in the SOP archives.

RESOURCES: Handbook of SOPs for Good Clinical Practice, 2nd Edition, Celine M. Clive

TOOLS: N/A