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
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
- Identify protocol documents to be archived.
- Request protocol termination verification from the Protocol Review Office (PRO).
- Request approval to archive protocol documents from protocol Principal Investigator.
- Confirm the Principal Investigator’s approval in writing or in email.
- Verify records have been retained on site for 2 years before archiving:
- After FDA approval was given for the drug for the indication for which it was investigated
- If no application was filed, or the application was disapproved
- The investigation was discontinued and the FDA was notified
STEP 2: Obtain Archiving Materials
- Place an order for archiving boxes with your purchasing officer or administrative officer:
- Required NIH archiving materials must be used
- Standard Record Box # 8115-00-117-8344 (size 14 3/4 in x 12in x 9 1/2in)
- Prepare boxes and complete Standard Forms (135 and 135a) as per archiving guidelines:
STEP 3: Prepare Research Documents
- Locate and assemble the research documents identified for archiving.
- Remove the documents from their binders and remove all non-official papers (e.g. post-it notes) from the documents.
- Make an inventory list of each box including patient record ID numbers, the quantity and type of each document.
- Place documents in the boxes; fill to 3/4 capacity each box.
- Overfilled or bulging boxes will not be picked up.
- Complete the SF 135 (and 135a if needed).
STEP 4: Obtain Approval to Archive from the NCI Records Management Officer (RMO)
- Send an email to the RMO (as of 10/2009, Karen Hubbard)
- RMO email = HubbardK@mail.nih.gov
- stating you have records to archive
- request an accession number:
- OMA telephone: 301-496-6985
- Attach a completed SF 135 and SF 135a to the email request.
- This request can also be faxed to: 301-402-2188.
- RMO will return a confirmation receipt of the request.
- Contact the RMO if you do not hear from the officer in 24 hours.
- RMO will email your approval to archive and include:
- assigned accession number
- eSF 135 with approval comment(s)
- If modifications need to be made to your request, the RMO will:
- Notify you via email or phone
- Provide instruction on how to make corrections
- The approval process may take up to 2 weeks
STEP 5: Archive the Records
- Follow the instructions in the approval email from the RMO.
- Write the accession number on your SF 135 and SF 135a forms.
- Place a hard copy of the approved SF 135 inside Box # 1 on the top of the documents.
- Place the boxes in the same location that you noted on the SF 135.
- Mark boxes with a removable label stating:
- "Approved for pickup on (date)".
- The approval email will give you a timeframe for pick-up, but may take up to 2 weeks.
- Someone must sign for the documents at time of pick-up:
- A charge will be incurred for unsuccessful pick-ups when no one is available to sign or the boxes are filled over three-fourths full.
STEP 6: Document the Process
- Document the archiving process per branch policy or SOP.
- Keep a copy of all completed SF 135 forms, archiving notes, and email correspondence for your records.
- Locate and store the copies of the RMO’s approval email, and SF 135 and 135A forms in a central location.
- Notify the Principal Investigator in writing that the archiving process was successful.