CTSU eCourse: Register with the CTSU

PROTOCOL-SPECIFIC SITE REGISTRATION DOCUMENTATION

Click to print page > > >

The following documents are required by the CTSU for protocol-specific site registration.

IRB/Regulatory Approval Transmittal Form

The IRB/Regulatory Approval Transmittal Form is faxed with the site registration documents. The form provides basic information needed by the CTSU to initiate the site registration review and will be used as a checklist to ensure that the required documents are submitted.

IRB Approval Documentation

A site must document IRB approval prior to screening, enrolling, and registering patients onto a study protocol. The Federal regulations that address Institutional Review Boards are available on the Helpful Related Links page in the Resources section of the CTSU Registered Member Web Site. Compliance with these regulations is intended to protect the rights and welfare of patients involved in research studies. Protocol The site forwards the protocol to the local Institutional Review Board (IRB) for approval. It is strongly recommended that the IRB provide documentation of approval using the CTSU IRB Certification Form. However, a formal letter of approval from the IRB or use of the Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of exemption (formerly HHS 310) form is acceptable. The IRB approval must clearly identify the following information:
	Protocol Title (may use shortened version)
	CTEP Assigned Protocol Number
	Current Protocol Version Date (required only when submitting version approvals)
	Institution name and CTEP Institution Code
	OHRP Assurance Number or all institutions covered by the IRB approval
	Principal Investigator name and CTEP Investigator number
	Type of Review (original, renewal, or amendment)
	Type of approval (full, expedited, or facilitated)
	Date of effective review and expiration date if less than 364 days
	IRB number if institution is using an FWA
	Signature of Authorized Individual from the IRB
If the CTSU IRB Certification Form is used, the PI, Research Nurse, or CRA may complete lines #1 through 8 on the form. The IRB representative must complete lines #9 through 20. The PI, Research Nurse, or CRA may not sign line #17; the IRB signatory must provide his or her signature. The form can currently be used to reflect approval for more then one institution if all other items on the form are identical. For example, two institutiona undergoing initial IRB review on the same protocol with the same PI may be entered on the form, but initial and continuing reviews should not be entered on the same form. A Supplemental Form is also available to enter additional sites if needed. Further information on completion of the transmittal form and IRB certification form is available on the CTSU web site under the RSS tab. A guidance document to completing the CTSU IRB Certification Form and the CTSU Transmittal Sheet is available under the RSS tab.
Return to Top

IRB-approved Informed Consent Form

A copy of the IRB-approved consent form must be submitted with the site registration materials for NCIC, CALGB, IBCSG and MD Anderson. A sample informed consent form is found in the protocol document and is also available in the Site Registration documents on the Protocol page of the CTSU Registered Member Web Site. Use the section in the sample informed consent that refers to "risks" and "alternative therapies" in its entirety. The sponsoring Group will indicate in the protocol (or as bolded font), those sections of the sample consent that require verbatim statements to the patient.

The local IRB must justify in writing changes made to the required sections of the sample informed consent. The justification is then submitted to CTSU. Changes to the risks and alternatives section of the model informed consent or other changes that modify the overall meaning of the consent form should be approved by your IRB and the Cooperative Group prior to the submission of site registration materials to the CTSU Central Regulatory Office. Please follow the instructions as outlined in the protocol for guidance on making substantial changes to the model informed consent document.

Prior to submitting protocol documents to the local IRB, the site investigator should review the sample informed consent and ensure that the site protocol consent form contains the following elements:

	Statement that the study involves research.
	Explanation of the purpose of the research.
	Explanation of the expected duration of the study.
	Description of the study procedures.
	Identification of experimental procedures.
	Description of the foreseeable risks from the study treatment or procedures.
	Description of any benefits to the subject or to others that may reasonably be expected from the research.
	Disclosure of the appropriate alternative procedures of courses of treatments, if any, that may be advantageous to the subject.
	Statement describing the extent to which confidentiality of records identifies the subject (this is mandated).
	Explanation of the availability of compensation or medical treatment if injury occurs and, if so, describe and provide a contact for further information.
	Explanation of whom to contact for answers to pertinent questions about research and the research subject's rights (IRB contact person).
	Voluntary participation statement making clear that there is no penalty for refusal to participate in the study or any portion of the study and that the patient may withdraw from the study at any time.
The informed consent may contain additional elements. When appropriate, provide one or more of the following elements of information to each patient:
	Statement that the particular treatment or procedure may involve risks to the patient (or to the embryo or fetus, if the patient is or may become pregnant) which are currently unforeseeable.
	Anticipated circumstances under which the patient's participation may be terminated by the investigator without regard to the patient's consent.
	Any additional cost to the patient that may result from participation in the research.
	Consequences of the patient's decision to withdraw from the research and procedures for orderly termination of participation by the patient.
	Statement that significant new findings developed during the course of the research that may relate to the patient's willingness to continue.
	Approximate number of patients involved in the study.
For more information on the required elements of the informed consent, see 45 CFR 46.116 (a), (b) and 21 CFR 50.25. These links are available in the Resources section of the CTSU Registered Members Website.

Return to Top