Clinical Research Operations

POLICY TITLE: Developing and Maintaining Standard Operating Procedures (SOPs)

POLICY STATEMENT: All Standard Operating Procedures (SOPs) for the Center for Cancer Research (CCR) will be developed, maintained, and updated in compliance with this SOP. CCR staff will have input into the development of SOPs. Staff will receive appropriate training for required SOPs.

SCOPE: This policy applies to the written standards and procedures followed by the CCR related to the development, maintenance, and training concerning all SOPs.

CONSIDERATIONS/REFERENCES/DEFINITIONS:

• Standard Operating Procedure: Detailed, written instructions to achieve uniformity of the performance of a specific function. (ICH/GCP, E6)

• Standard Operating Procedures for Good Clinical Practice at the Investigative Site. Thomsen, Center for Clinical Research Practice, 2003.

• SOP Writing for Clinical Trials: Staff Training Aspects. Akanksha Saxena, International Biopharmaceutical Association Publication, 2001.

• QA for the Investigative Site, Applied Clinical Trials. Ann Neuer, Barry Miskin, Nov 2004.

REGULATIONS/GUIDELINES:

• International Conference on Harmonization; Good Clinical Practice Guidelines, E6, Section 1.55
• 21 CFR 312.60 General Responsibilities of Investigators

RESPONSIBILITY: It is the responsibility of the staff of the CCR involved in the management of clinical trials to read, review, and comply with the SOPs of the CCR.