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Expedited approval for any CRC protocol shall be granted to permit
earlier implementation of minor protocol changes, to minimize CRC
Scientific Advisory Committee (SAC) workload, or under special
circumstances, when full SAC review would unduly delay the start of a
previously reviewed protocol. The CRC Program Director or an Associate
Program Director, in consultation with the SAC Chair, shall decide if an
expedited approval request will be reviewed by the administrative team
with subsequent SAC confirmation, or if full SAC review is more
appropriate. |
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The following
procedures will be followed without exception to ensure the integrity of
the CRC Scientific Advisory Committee review process: |
| 1. |
The Principal
Investigator shall submit the following: |
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a. |
A
letter of request for expedited approval detailing the changes to the
currently approved protocol with justification for such changes
addressed to the CRC Administrative Director. |
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b. |
The
revised protocol with all changes highlighted. |
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c. |
The
revised consent form. |
| 2. |
The Administrative
Director shall distribute the letter and application materials to the
following CRC personnel for their review: |
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a. |
Program Director
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b. |
Associate Program
Director(s) |
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c. |
Biostatistician |
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d. |
Core Laboratory
Director |
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e. |
Research Subject
Advocate |
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f. |
Nurse Manager |
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g. |
Informatics Core
Director |
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h. |
SAC Chair |
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i. |
Research Dietician |
| 3. |
A tracking sheet (see
Attachment A) shall be in the
CRC file with the protocol, and each of
the above noted individuals shall sign off on the approval or send an
e-mail approval that documents concurrence (which will also be
maintained in the CRC file). |
| 4. |
Any concerns by the
administrative reviewers regarding the expedited approval request shall
be communicated in writing to the Program Director. Any concerns must
be resolved before expedited approval is granted. |
| 5. |
The Administrative
Director shall send a letter of expedited approval to the Principal
Investigator following full concurrence by the administrative
reviewers. Expedited approval will represent temporary approval until
confirmation at the next regular SAC meeting, at which time full
approval will be considered. If the SAC Chair, Program Director, or
Associate Program Director, after consideration of administrative
concerns is uncomfortable with expedited approval, the protocol will be
assigned to two SAC reviewers and will undergo full review. |
| 6. |
The CRC SAC shall vote to confirm all administrative actions. |
| 7. |
The dates of both the
Expedited Approval and final SAC approval for the expedited approval
must be documented on the tracking sheet. |
