Clinical Research Operations

Nomenclature for Protocol Documents and Files

Purpose: Protocol documents, files and file folders will be created, named, and maintained in a consistent manner to ensure security, efficiency, and continuous access.

Step 1:

Action: Create and maintain protocol folders for each new protocol

A. Each new protocol will have a folder on a central secure server for documentation of protocol actions and documents.

B. Folders will be created based on the submission requirements of the individual protocol Concept Review Committee (CRC).

• Scientific Review Committee (SRC)
• Institutional Review Board (IRB) Initial
• Sponsor/CTEP
• Amendments
• Continuing Reviews
• Radiation Safety Committee (RSC)
• Office of Biotechnology Activities (OBA)
• Institutional Biosafety Committee (IBC)
• Data and Safety Monitoring Board (DSMB)
• Safety Monitoring Committee (SMC)
• Investigator’s Brochure (IB)
• Investigational New Drug Application (IND)
• Subfolders will be specified by Serial number submissions, i.e., SN0000 initial submission, SN0001 amendment A.
• Clinical Center Standardization Committee Review

Note: Each folder may include the subfolders, as applicable (i.e., Drafts, Appendices, Consents, etc.)

Step 2:

Basic naming convention standards for protocol documents will be followed.

A. The standard document naming convention standard is:
<Short Name of Protocol> Document Title Document Category Document Date

Note: All CTEP naming conventions are the same as the standard, simply add CTEP # in front of
the short name. Example: <CTEP #short name>Initial Protocol Date

B. The standard format and rules for Date(s):

1. Format: MM-DD-YY
2. Meeting minute document Dates = meeting date
3. Protocol and subsequent amendments document Dates = protocol version date
4. Consent document Date = consent version date
5. IB Date = version date

C. Additional renditions of protocol documents based on stipulations would include the numeric identifier.

Note: Example: <short name> resp to SRC stips#2 protocol tracked date
Example: < CTEP #short name> resp to CTEP stips#2 protocol tracked date

D. Listed below are standard naming conventions for submissions:

1. Concept review

• CTEP LOI: LOI <short name> PI Name date MM-DD-YY
• Example: LOI MDX010 Steakley 01-15-10

2. Initial submissions (SRC, IRB, CTEP)

• <short name> Protocol date
• <short name>Initial Protocol date
• Example: MDX010 Initial protocol 01-15-10
• <short name>Initial Consent date

3. Responses

• <short name> resp to Committee Acronym stips protocol tracked date
• <short name> resp to Committee Acronym stips protocol clean date
• <short name> resp to Committee Acronym stips consent tracked date
• <short name> resp to Committee Acronym stips consent clean date

4. Amendments

• <XXCXXXX Amendment Letter> Protocol tracked date
• Example: 10C0025A protocol tracked 01-15-10)
• <XXCXXXX Amendment Letter> Consent tracked date
• <XXCXXXX Amendment Letter> Protocol clean date
• <XXCXXXX Amendment Letter> Consent clean date

• <CTEP #short name>amend # protocol tracked date
• <CTEP #short name>amend # protocol clean date
• <CTEP #short name>amend # consent tracked date
• <CTEP #short name>amend # consent clean date

5. Memos

• <short name> Committee Acronym approval memo date
• <short name> resp to Committee Acronym memo date

• <XXCXXXX Amendment Letter> Cover memo date

• <CTEP # short name >Initial Cover memo date
• <CTEP #short name>amend # cover memo date
• <CTEP# short name>amend # Approval memo date

• <short name OBA/IBC Amendment letter> cover memo date
• <short name OBA/IBC SAE form> cover memo date

6. Minutes

• <short name> Committee Acronym Minutes date

7. OBA/IBC

• <short name OBA/IBC> application date

8. RSC

• <short name RSC> application date

9. DSMB

• XXCXXXX Amendment Letter DSMB report date

10. IB

• <Drug Name IBvX.x> date
• Example: MDX010 IBv6.2 12-10-09

11. Clinical Directors' Signatures

• <short name> <institute> clinical director signature date