CTSU eCourse: Register with the CTSU

Register

OBJECTIVE 4: PROTOCOL-SPECIFIC SITE REGISTRATION

Module Objectives
1	Summarize CTSU pre-registration information for Cooperative Group members
2	Initiate CTSU registration of Cooperative Group members
3	Explain the qualification process whereby investigators not affiliated with a Cooperative Group can be credentialed as CTSU members
4	Identify the protocol-specific registration process and regulatory requirements that enable a site to participate in a clinical trial through the CTSU
5	Define the sequential steps in the patient registration process

PROTOCOL AMENDMENTS

The lead Cooperative Group determines the nomenclature for protocol amendments and their distribution.

The CTSU will send an immediate e-mail message when a protocol change addresses a patient safety issue. Other protocol amendments will be announced via the bi-monthly broadcast e-mail message. The CTSU will follow the instructions given by the Cooperative Group sponsoring the protocol to determine the type of IRB review recommended.

If the original protocol is amended:

The site must forward the amendment and supporting documentation to the local IRB for review.
If the amendment necessitates a change in the consent, the revised consent accompanies the IRB submission documents.
It is critical that the site submits protocol amendments to their IRB within the time frame requested by the sponsoring Cooperative Group.
The NCI/CTEP Cancer Trials Monitoring Branch (CTMB) guidelines state that an amendment should be submitted immediately to the IRB and an approval obtained within 60-90 days.

IRB Amendment Approval Documentation

If the CTSU indicates that proof of IRB Protocol Amendment Approval is needed, an updated version of the following documents should be provided to the CTSU and reflective of the new amendment:

IRB/Regulatory Approval Transmittal Form
CTSU IRB Protocol Certification Form, IRB Approval Letter, or HHS/NIH Form 310
IRB-Approved Consent (date stamped or signed and dated by the IRB chair)

The Regulatory Coordinator reviews all protocol amendment approval documents within 24 to 72 hours after receipt at CTSU. If all elements on the documents are complete, the CTSU notifies the site contact person and conveys approval of the amendment materials by e-mail. If the paperwork is incomplete, the CTSU notifies the site that additional information is needed.

Once the IRB has approved the amendment and revised consent, the investigator destroys all unsigned copies of the old consent, retaining one copy in the regulatory files. The sponsoring Cooperative Group will direct whether patients currently receiving treatment must review and sign the new consent. Versions of the consent previously signed by the patient must be retained in the patient's protocol file.