Clinical Research Operations

SOP Review and Approval Process

Purpose: To identify the process for submitting a Standard Operating Procedure (SOP) for review and approval

STEP 1: Submit SOP

1. The SOP author submits SOP to the CCR Quality Assurance (QA) Officer.
2. The CCR QA Officer will review the SOP for content, format, and completeness.
   • Changes will be discussed and made with author as needed.

STEP 2: Submit SOP to the Office of the Clinical Director

1. The CCR QA/QC Officer will send the updated SOP to the Office of the Clinical Director (OCD) to review.
2. The SOP will be sent in electronic format.
3. The OCD will review and edit or approve the SOP.
   • Note: The OCD will solicit assistance from technical experts to review when applicable.

    4.  Changes identified by the OCD will be sent to the QA Officer within 2 weeks from initial review date.

    5.  The CCR QA Officer will collect and document all proposed edits to the SOP.

    6.  The OCD will perform a final review before posting for Public Comment or final approval.

STEP 3: Submit SOP for Public Comment

1. When applicable, a SOP will be posted on the CCR Clinical Research Operations Wiki site under the NCI-CCR Policies and SOPs section, "CCR Public Comment (DRAFTS)".
   • Note: SOPs written for previously approved and mandatory processes will not be posted for Public Comment.
2. The CCR QA Officer will send an email notification to the CCR staff that an SOP has been posted
   for Public Comment.
3. Staff may submit edits/comments by faxing the edited document to 301-496-9020 or emailing edits to the QA Officer.
   • All edits are logged in and reviewed by the Office of the Clinical Director, Senior Research Nurse Committee or appropriate Technical Expert.
4. The Office of the Clinical Director will review all Public Comments to determine appropriateness for the SOP.
5. If Public Comments result in any major changes to the SOP, the SOP will be sent through the review process again, starting at Step 2.

STEP 4: Submission of SOP for Final Posting

1. The CCR QA Officer will review SOP in final format, verify references, update tracking log, and update the CCR Clinical Research Operations Website with the approved SOP.
2. QA Officer will conduct final review of SOP on website.

STEP 5: Notification of Approved SOP

1. The QA Officer will email the CCR Principal Investigators, Research Nurses, and the Data Management contract staff to announce the posting of the approved SOP(s).
   • The URL to the SOP, any pertinent instructions, and any in-service information will be included.