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Section: Core Facility
Subject: Standard Operating Procedures / Policies
XIV APPENDICES (only if applicable) a separate page listing all appendices shall be present for all SOPs
with appended forms or other documents.
D. HISTORICAL OUTLINE
The final (second to final if appendices are present) page of all SOPs must contain an historical record in
tabular format. Each line of the table shall be for a specific revision of the SOP. The table columns shall be
used as follows:
DATE: Date of first writing, revision, review and removal of service.
WRITTEN/REVISED: Name of person who wrote or revised that procedure.
REVISON DESCRIPTION: Description of the revisions of that procedure.
MANAGER REVIEW: Signature block for the facility manager to indicate review of the policy /
procedure.
FACILITY DIRECTOR REVIEW: Signature block for the facility director to indicate review of the
policy / procedure.
MEDICAL DIRECTOR REVIEW: Signature block for the relevant medical director(s) to indicate review
of the policy procedure.
Because procedural SOPs are for the generation of products for human administration, their production may
have medical implications.. Accordingly, all procedural SOPs must be reviewed and signed by the relevant
medical director (i.e. â BMT medical director to sign for BMT specific SOPs, the immunotherapy medical
director to sign for immunotherapy specific SOPs). Administrative, Quality, Maintenance and Computer SOPs
do not generally have medical implications, and, on the determination of the facility director, may be placed in
service without medical director or principal investigator review. In these instances the medical director
signature block must be completed with the words NOT REQUIRED, and must be initialed by the facility
director.
PRINCIPAL INVESTIGATOR REVIEW: Signature block for the principal investigator of IND/IDE
associated clinical trials to indicate review of the policy/procedure.
Only SOPs that are associated with clinical trials and/or IND/IDE require principal investigator review and
signature. SOPs that are determined by the Facility Director to not require this review must have this block
completed with the words NOT REQUIRED, and must be initialed by the facility director.
E. ASSOCIATED FORMS AND APPENDICES
All forms associated with an SOP must follow that SOP as appendices. In the hard copy file, the form
must be completed with mock data to serve as an example for completion. Forms must also be numbered,
with the numbering system as follows:
o Forms numbers must be based on the associated SOP number, but are designated as forms by the
prefix âFâ. Thus, the second revision of a form associated with this SOP would be numbered FCTF-I-
001.2.
o If there is more than one form associated with a particular SOP, then they should be distinguished by
alphabetic suffixes. For example, because there are multiple forms associated with this SOP, they are
numbered FCTF-I-001A, FCTF-I-001B.3, etc
Other appendices may follow an SOP, behind any associated forms. Examples of appendices are tables of
values, nomograms, and copies of reference materials that are not otherwise easily accessed.
File name:
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POLICIES & PROCEDURES
