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:
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.
