SMILE
Johns Hopkins University
Baltimore, MD USA
CHECKLIST FOR SITE SOP REQUIRED ELEMENTS:
General SOP Required Elements
Author: Erin Gover / Document Number: / Pro71-06Effective (or Post) Date: / 29-Oct-08
Review History / Date of last review: / 20-May-10
Reviewed by: / Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.
Topic: / Laboratory: SOPs
Site SOP Title/Number:
Designated Site SOP Reviewer:
Study Program:
Study Site:
Element
Present / GENERAL SOP REQUIRED ELEMENTS
The title of the SOP is identifying in purpose and is brief and direct.
Each page of the SOP contains page numbers of total pages and the version number.
There is evidence that the procedure has been approved by the appropriate individual on an annual basis.
Necessary forms are attached to the document, and if not, they are available to review to determine if they are consistent with SOP text.
The purpose of the SOP simply states its purpose.
Terms that need clarification are defined.
The SOP procedures provide instructions for “how to do” a particular task in a stepwise fashion.
Forms, diagrams and drawings are easy to understand and are consistent with text.
The author of the document is noted.
References used as the source of information are included.
Comments: Required elements are described in CLSI GP-A4.
Initial Review Comments/Recommendations to the Site: / Further Revisions Needed
No Further Revisions Needed
Comments entered here.
Initial Review by:
Date of Initial Review:
Review Comments/Recommendations to the Site: / Further Revisions Needed
Approved
Reviewed by:
Date of Review:
Final Review Comments/Recommendations to the Site: / Further Revisions Needed
Approved
Reviewed by:
Date of Review:
Pro7.1-01 SOP Checklist - General SOP Requirements V4.0 Page 1 of 2 5/20/2010