Archiving Research Documents

SOP #: ADCR-11

Next Review Date: 10/2011

Version #: 1.0

Review Interval Period: Biennial

Approved Version #: 1.0 Date: 10/2009

Policy Reference:

Purpose: To describe the activities involved with archiving research documents in the Center for Cancer Research (CCR)
STEP 1: Obtain Approval to Archive Research Documents
  1. Identify protocol documents to be archived.
  2. Request protocol termination verification from the Protocol Review Office (PRO).
  3. Request approval to archive protocol documents from protocol Principal Investigator.
  4. Verify records have been retained on site for 2 years before archiving:
STEP 2: Obtain Archiving Materials
  1. Place an order for archiving boxes with your purchasing officer or administrative officer:
  2. Prepare boxes and complete Standard Forms (135 and 135a) as per archiving guidelines:
STEP 3: Prepare Research Documents
  1. Locate and assemble the research documents identified for archiving.
  2. Remove the documents from their binders and remove all non-official papers (e.g. post-it notes) from the documents.
  3. Make an inventory list of each box including patient record ID numbers, the quantity and type of each document.
  4. Place documents in the boxes; fill to 3/4 capacity each box.
  5. Complete the SF 135 (and 135a if needed).
STEP 4: Obtain Approval to Archive from the NCI Records Management Officer (RMO)
  1. Send an email to the RMO (as of 10/2009, Karen Hubbard)
  2. Attach a completed SF 135 and SF 135a to the email request.
  3. RMO will return a confirmation receipt of the request.
  4. RMO will email your approval to archive and include:
  5. If modifications need to be made to your request, the RMO will:
STEP 5: Archive the Records
  1. Follow the instructions in the approval email from the RMO.
  2. Write the accession number on your SF 135 and SF 135a forms.
  3. Place a hard copy of the approved SF 135 inside Box # 1 on the top of the documents.
  4. Place the boxes in the same location that you noted on the SF 135.
  5. Mark boxes with a removable label stating:
  6. The approval email will give you a timeframe for pick-up, but may take up to 2 weeks.
  7. Someone must sign for the documents at time of pick-up:


STEP 6: Document the Process
  1. Document the archiving process per branch policy or SOP.
  2. Keep a copy of all completed SF 135 forms, archiving notes, and email correspondence for your records.
  3. Locate and store the copies of the RMO’s approval email, and SF 135 and 135A forms in a central location.
  4. Notify the Principal Investigator in writing that the archiving process was successful.