A Manual for Participants in Clinical Trials of Investigational Agents ...

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• Disapproved - In the judgment of the PRC, the protocol cannot be approved even with major revisions. 8.4.4 The Review of the Informed Consent The PRC also reviews the informed consent document to be certain that: • The document includes all required elements of informed consent mandated by Federal regulation; and • The description of potential benefits and adverse events is complete and accurate. Investigators should communicate changes made to the consent document resulting from a CTEP review to their IRBs. It is not CTEP’s intent for their informed consent review to supplant IRB review. Provided the consent document meets the requirements of regulation and law and contains sufficient information to enable an individual to make an informed choice, the local IRB approval of the content is generally to be regarded as definitive. Individual institutions may make minor changes to the CTEP-reviewed informed consent form. However, by the originator of the informed consent document must approve any changes in risks or alternative procedures. 8.4.5 The Review of Regulatory and Administrative Concerns The PRC reviews each protocol to assure proper instructions for reporting adverse events are included, an accurate and up-to-date pharmaceutical section is provided, and necessary instructions for multicenter trials are given, if appropriate 8.4.6 The Review by the Pharmaceutical Collaborator In cases where a Pharmaceutical Collaborator is involved, CTEP forwards protocols received to the Collaborator for review and comment approximately two weeks before it is reviewed by the PRC. CTEP discusses Collaborator comments if they are received before the Protocol Review Committee meeting. They give them due consideration, and comments from either Collaborator or the CTEP staff that are agreed upon in the PRC meeting are included in the consensus review. 8.4.7 The Consensus Review After the PRC meeting, the primary reviewer generates a consensus review that states the PRC’s collective concerns. PIO sends this consensus review with a cover letter stating the summary PRC decision to the protocol originator within approximately 30 days of receipt of a complete protocol. 8.4.8 Responding to CTEP Consensus Review If the protocol or the informed consent requires revisions, the investigator should send a revised submission to the PIO. A complete submission includes the revised protocol and informed consent with a cover letter that details the responses to the points raised in the consensus review. If CTEP reviewers find the response satisfactory, then the protocol goes forward for final approval. CTEP’s consensus reviewer may choose to send the revised protocol back to the full PRC for further consideration. If the PRC still does not accept the protocol, CTEP sends a letter to the investigator detailing remaining CTEP concerns. The investigator should Section 8 - Investigator’s Manual 2009 42
espond to this re-review in the same way as described for the initial consensus review. This process continues until the science, regulatory, and administrative aspects, and informed consent are each accepted or the study is withdrawn or disapproved. Each evaluation of a revised study requires an average of 10 to 30 days. 8.5 Protocol Document Approval Upon final acceptance of the protocol and the informed consent, as indicated by the concurrence of the consensus reviewer and appropriate CTEP staff, CTEP sends a letter of protocol approval the protocol originator. Please note that protocol approval will not be given by telephone. Although CTEP staff may discuss the study with protocol chairs, they should consider nothing official until they receive written notice via email. After PIO sends written approval, PMB will accept orders for investigational agents. All approved protocols using DCTD-sponsored agents are submitted to the FDA as part of the IND file. 8.6 Amendments Any change to the approved protocol document must be documented point by point in a cover letter, and a replacement page(s) or a revised protocol document and informed consent submitted to the PIO. Please reference the NCI protocol number, date each amendment, and document version number sequentially for each study. Upon receipt, CTEP staff reviews each amendment. Further detailed guidance on amendment submissions can be found in the CTEP Amendment Request Submission Policy: http://ctep.info.nih.gov/protocolDevelopment/default.htm#amendments. 8.7 Study Status Investigators should communicate changes in study status to the CTEP PIO immediately. The following list shows the categories of study status recognized by CTEP and PDQ: • AP (Approved) – Protocol has received final CTEP approval. • AC (Active) – Trial is open to accrual. • TC (Temporarily Closed to Accrual) – Protocol is temporarily not accruing. • TB (Temporarily Closed to Accrual and Treatment) – Protocol is temporarily not accruing and patients are not receiving therapy. • CA (Closed to Accrual, Patients still on Treatment) – The protocol has been closed to patient accrual. Patients are still receiving therapy. • CB (Closed to Accrual, All Patients have Completed Treatment) – The protocol has been closed to patient accrual. All patients have completed therapy, but patients are still being followed according to the primary objectives of the study. No additional investigational agents are needed for this study. • CP (Completed) – The protocol has been closed to accrual, all patients have completed therapy, and the study has met its primary objectives. A final study report/publication is attached or has been submitted to CTEP. • AD (Administratively Completed) – The protocol has been completed prematurely (e.g., due to poor accrual, insufficient agent supply, IND closure). The trial is closed to further accrual, and all patients have completed protocol treatment. A final study report (see below) is not anticipated. Section 8 - Investigator’s Manual 2009 43
Page 1 and 2: A Manual for Clinical Investigators
Page 3 and 4: 7.1.3 Purpose .....................
Page 5 and 6: 13.4 Responsibilities of Clinical S
Page 7 and 8: 1 Introduction This manual explains
Page 9 and 10: drugs and biologics rests with the
Page 11 and 12: costs might include additional labo
Page 13 and 14: 3 The Clinical Trial Site and the I
Page 15 and 16: CTEP's site visit monitoring progra
Page 17 and 18: 4 Phase 1 Trials The Development of
Page 19 and 20: Because the correlation between sch
Page 21 and 22: for organ dysfunction studies. The
Page 23 and 24: efore writing a formal LOI. IDB sta
Page 25 and 26: CTEP has based its guidelines conce
Page 27 and 28: 5.1.4 Randomized Phase 2 Studies A
Page 29 and 30: • Physician members of CCOPs for
Page 31 and 32: 6 Phase 3 Trials 6.1 Scientific Pol
Page 33 and 34: completed by the Cooperative Group
Page 35 and 36: clinical trial participation to all
Page 37 and 38: proposer that the submission will n
Page 39 and 40: at the FDA, and for the listing of
Page 41 and 42: expected adverse events that the pa
Page 43 and 44: • How dose modifications will be
Page 45 and 46: consent forms. However, the informe
Page 47: Investigators’ failure to submit
Page 51 and 52: 9 Ordering Investigational Agents f
Page 53 and 54: the local oncologist(s) must regist
Page 55 and 56: phase 1 include the first time the
Page 57 and 58: investigator send an additional cop
Page 59 and 60: • Altering existing research by m
Page 61 and 62: CTEP has devised a detailed policy
Page 63 and 64: 13 Affiliate Investigators The part
Page 65 and 66: 13.4.3 Cancer Centers The Cancer Ce
Page 67 and 68: 14.3 Administration of Investigatio
Page 69 and 70: • Agents are stored in various pl
Page 71 and 72: 16 Monitoring and Quality Assurance
Page 73 and 74: 16.5 Components of the Quality Assu
Page 75 and 76: Also, please note that medical reco
Page 77 and 78: • Even if the agent has been repo
Page 79 and 80: Appendix I NCI-Cooperative Group-In
Page 81 and 82: Phase 0 trials do not replace phase
Page 83 and 84: phase 2 trials enroll 20-30 patient
Page 85 and 86: the study should be ordered under t
Page 87 and 88: Appendix IV Key Contact Information
Page 89 and 90: Appendix V Informed Consent Checkli
Page 91 and 92: 2. Describe risks as outlined in th
Page 93 and 94: CLINICAL SITE: An institution, coop
Page 95 and 96: RAB: Regulatory Affairs Branch, htt
Page 97 and 98: • Agent preparations must be perf
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Procedure for Acute Exposure or Spi
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Appendix VIII National Cancer Insti
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7) Investigational Drug Accountabil
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• Write treatment instructions cl
Page 107 and 108:
• For agent admixtures that can b
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