CTSU eCourse: IRB Approval Documentation

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-SPECIFIC SITE REGISTRATION DOCUMENTATION

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 site registration review and is used as a checklist to ensure that the required documents are submitted.
IRB Approval Documentation of Protocol
The site forwards the protocol to the local IRB for approval. It is strongly recommended that the IRB provide documentation of approval through the CTSU IRB Protocol Certification Form. However, a letter of approval from the IRB or use of the HHS/NIH Form 310 is also acceptable.

The IRB approval must clearly identify the following information:
- Protocol Title (not mandatory on HHS/NIH Form 310 or CTSU IRB Protocol Certification Form)
- CTEP Assigned Protocol Number
- Current Protocol Date, Revision Number, and/or Amendment Number
- Type of IRB Review (Full or Expedited)
- Signature of Authorized Individual from the IRB
- Approval Date
- OHRP Assurance Number of the Organization Providing Assurance for this Protocol
If the CTSU IRB Protocol Certification Form is used, the PI, Research Nurse, or CRA may complete lines #1-5 on the form. The IRB representative must complete lines #6-14. The PI, Research Nurse, or CRA may NOT sign on line #13; the IRB signatory must provide his/her signature.
IRB-approved Informed Consent Form
A copy of the IRB-approved consent form is submitted with the site registration materials. A sample informed consent form is found in the protocol document and separately in the Site Registration documents on the Protocol page of the CTSU Registered Members Website. 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 to the required sections of the sample informed consent. The justification is submitted to the CTSU.

Prior to submitting protocol documents to the local IRB, review the sample informed consent as a reference and ensure that the site protocol consent form contains the following elements:
- A statement that the study involves research.
- An explanation of the purpose of the research.
- An explanation of the expected duration of the study.
- A description of the study procedures.
- An identification of experimental procedures.
- A description of the foreseeable risks from the study treatment or procedures.
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A disclosure of the appropriate alternative procedures of courses of treatments, if any, that may be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- n explanation of the availability of compensation or medical treatment if injury occurs, and if so, what they consist of and whom to contact for further information.
- An explanation of whom to contact for answers to pertinent questions about research and the research subject's rights (IRB contact person).
- A voluntary participation statement that states that there is no penalty for refusal to participate in the study or any portion of the study and no penalty for withdrawal from the study.
The informed consent may contain additional elements. When appropriate, one or more of the following elements of information shall also be provided to each patient:
- A 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) that 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.
- The consequences of the patient's decision to withdraw from the research and procedures for orderly termination of participation by the patient.
- A statement that significant new findings developed during the course of the research may relate to the patient's willingness to continue participation.
- The 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.
Personnel Contact List is a protocol-specific form that provides the name and contact information for all members of the researcher's team, including the PI, Radiation Oncologist, if applicable, Research Nurse, CRA, Data Manager, and Pharmacist, involved with the conduct of the study.