How do I know where to send my Institutional Review Board (IRB) approval information?

 

Refer to Section 5.0 of the protocol for study specific instructions. In general, the majority of GOG trials require that an official signed CTSU IRB Certification Form and a CTSU IRB/Regulatory Approval Transmittal Sheet (forms can be downloaded at http://www.ctsu.org) be sent to the CTSU Regulatory Office. However, specific trials require that the IRB approval information and additional regulatory documents (e.g. FDA Form 1572, Financial Disclosure Form, Investigator Signature Page) be submitted by mail directly to the GOG Regulatory Department at the Administrative Office.

 

 

Do I send the original signed regulatory documents or copies?

 

When the GOG or a Pharmaceutical Company requires signatures on regulatory documents (e.g. FDA Form 1572, Financial Disclosure Form, Investigator Signature Page), the original signed regulatory document must be submitted. Copies of these original signed documents should be retained in your institutional regulatory binder.

 

 

Does my Principal Investigator and Sub-Investigators need to sign and date their Curriculum Vitae (CV)?

 

Yes, all investigators must sign and date their CV. The CV must be resubmitted annually.

 

 

Why do I need to include the NCI Version Date on the IRB approval and the Informed Consent?

 

The NCI Version Date must be included on the IRB approval and Informed Consent so that the GOG can track the version of the protocol and informed consent which was approved by your IRB. The most current version of the protocol and informed consent must be approved by your IRB before patient entries will be accepted for a specific trial. It it recommended that you check the protocol documentation page for each protocol to ensure that you have the current version.

 

 

Where can I find out who the IND Sponsor is and where can I find the IND number?

 

The Sponsor of the IND and IND number are listed in Section 4.0 of the protocol. The IND number can also be found in the title of the protocol.

 

 

How do I obtain a copy of an Investigators Brochure (IB)?

 

Refer to Section 4.0 of the protocol to determine how to obtain a copy of an Investigator Brochure. If a drug is supplied by the NCI, requests should be forwarded to the NCI IB Coordinator. All requests for IBs, for NCI-supplied drugs, should be e-mailed to ibcoordinator@mail.nih.gov or the IB Coordinator may be called at 301-496-5725. If a drug is supplied by a pharmaceutical company, the Investigator Brochure can be found on the GOG Member Access website on the protocol documentation page for a specific study. Section 4.0 of the protocol will include instructions for obtaining the Investigator Brochure if it is not available on the GOG Member Access website.

 

 

Who should be notified about Adverse Events and Serious Adverse Events?

 

Refer to Section 10.0 of each GOG protocol for specific instructions for reporting Adverse Events and Serious Adverse Evens for that trial. The mechanism for reporting Adverse Events and Serious Adverse Events may differ depending on the use of investigational agents and the sponsor of the IND. Adverse Event and Serious Adverse Events must be reported to the investigator's IRB according to local policies and procedures and filed in the protocol file.

 

 

How does a GOG Investigator obtain an NCI/CTEP Investigator Number?

 

In order to obtain an NCI/CTEP Investigator Number, the investigator must submit the following documents to the Pharmaceutical Management Branch (PMB) or the NCI:

  • FDA Form 1572

  • Curriculum Vitae (CV)

  • Investigator Supplemental Data Form

  • Financial Disclosure Form

These forms can be located on the NCI/CTEP website at

http://ctep.cancer.gov/investigatorResources/investigator_registration.htm.
Investivators must resubmit the FDA Form 1572 annually to maintain their active NCI status. The NCI/CTEP Investigator Number is required.

 

 

How long do I have to keep GOG study-related records, including IRB approvals?
 

GOG study-related records must be kept until the Protocol has been “terminated.” “Study termination” means that patient follow-up is being discontinued for those patients who were enrolled onto a particular study. Studies are terminated by the Protocol Committee, after the SDC has confirmed that no patients are continuing to receive treatments prescribed by the protocol. If a patient is enrolled on several studies but not all of these studies have been terminated, then follow-up is expected to continue in accordance with the non-terminated studies on which the patient is enrolled. Once a study has been terminated, a participating institution is no longer required to submit annual updates/renewals to its IRB. After a study has been terminated by the GOG, those patient charts that are at least 3 years old (from entry), and no longer subject to audit, may be destroyed.

 

 

What is the meaning of the term, “Study Closure?”

 

“Study closure” means that no more patients will be permitted to enroll onto the study. This occurs once the targeted sample size has been attained, or when the Data Monitoring Committee votes to prematurely stop the accrual onto a particular study. Some studies are designed to temporarily suspend patient enrollment in order to permit interim analyses. However, the term “study closure” is reserved for the case when there is no intention to resume enrollment.  

 

 

What is the policy regarding destruction of protocol documents once a study has been terminated?
 

All patients, regardless of whether they are dead or alive have to have their chart retained until that protocol is terminated. (Even though a patient may have died and more follow-up won't be sent, additional information may be requested until the paper is published.). Once the study is terminated, the chart can only be destroyed if the patient had been entered for more than three years as she may still be subject to audit.

 

 

 

 


 
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