|IACUC Policy:||Document Control|
|Policy #||IBT-100.00||IACUC Approval:||January 27, 2014|
To provide instruction for the management and maintenance of IACUC approved programs, policies, and forms.
This policy applies to all approved programs, policies, and forms subject to oversight by Texas A&M Health Science Center.
It is the responsibility of the IACUC office to review/revise, implement, and disseminate final versions of documents approved by the committee.
It is the responsibility of the IACUC to review and approve administrative documents pertaining to animal research, which include programs, policies and forms.
Form – a controlled, standard lay-out (format) used for transmitting or collecting data.
Policy – a definite course or method of action selected in light of given conditions to guide and determine present and future decisions.
Program – a system of procedures or activities that have a specific purpose, e.g. Occupational Health and Safety Program.
Draft copy – a version of an unapproved, unreleased document, or a mark-up version of an existing document intended for review and approval by the IACUC.
Effective date – the date a document becomes available for use.
I. Documentation Guidelines
- Each Policy will be formatted to include major sections: Purpose, Scope, Responsibilities and may also include but is not limited to: Definitions, General Policies and References (see Draft Policy Format 401).
- The header information will include title, document number, and IACUC approval date.
- A document history will be included at the end of the main body of the policy that includes all version numbers and approval dates.
- IACUC policies are assigned a pre-fix number of 100-200.
- 100 – Institutional
- 200 – Veterinary Care
- The next two digits are issued sequentially starting at .00 to indicate document version.
II. Documentation Processing and Implementation
Programs, policies and forms are created based upon institutional need and in accordance with applicable regulations.
2. Implementation and Approval
a. Upon creation, these documents will be initially reviewed by the IACUC.
b. The IACUC members will have an opportunity to approve, or request modifications, and set the effective date.
c. Upon approval and effective date determination, the IACUC office will disseminate documents to the research community.
3. Previously approved documents may be revised in one of three ways:
a. Administrative review- policies are reviewed by the IACUC Office and IACUC Chair-only for minor changes: i.e. typos, font, format, minor wording revisions
b. Designated member review-process would be as described in DMR policy 109. This is utilized for or minor revisions and updates.
c. Full committee review- major revisions and rewrites.
4. A yearly review of documentation will take place by the IACUC office to ensure continued adequacy. The policies will be provided to the full committees for yearly review and re-approval.
III. Record Retention
The electronic files of all approved documents shall be maintained by the IACUC office. All document approvals will be recorded in the meeting minutes.
IACUC administrative documentation will be retained for a period no less than 3 years (e.g., meeting minutes, inspection reports, policy and form versions).
All animal use documentation will be retained for a period no less than 3 years after closure of the protocol (e.g., Animal Use Protocols, Amendments, and Progress Reports).
Version 00 - Initial Approval: January 27, 2014