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

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8 Protocol Review and Approval at CTEP 8.1 The Protocol and Information Office (PIO) Within CTEP, the PIO manages the review process and maintains the official record of all CTEP-supported protocols, amendments, and protocol-related communications. PIO also manages all protocol submissions to the Physician Data Query (PDQ) system and FDA. The PIO maintains more than 10,000 protocols. All protocols and related correspondence should be sent directly to the PIO via email at pio@ctep.nci.nih.gov. The PIO will distribute all email to the appropriate CTEP physician staff. Please do not direct protocol-related materials to any other CTEP staff member as this will lengthen the time required for resolution or review. When submitting each new protocol, please also include the current version of the Protocol Submission Worksheet, http://ctep.info.nih.gov/protocolDevelopment/default.htm. Direct all telephone calls regarding status of protocol and amendment reviews to the PIO at 301-496-1367. 8.2 How to Submit a Protocol Send each new protocol directly to the PIO and include: • The electronic copy of the Protocol Submission Worksheet, • An electronic copy of a paginated, legible protocol, including a local protocol number. Please be certain the protocol document contains information about each of the topics listed in Section 7.2 and Section 7.3. If these items are missing or incomplete, PIO will return the submission to the protocol source without review. Upon receipt, PIO assigns an NCI protocol number to each protocol, and acknowledges your protocol submission with the NCI-assigned protocol number. You must reference this NCI protocol number in all subsequent communications with CTEP regarding this study. Assignment of this number does not imply approval; only the final approval letter signifies approval and the authorization to order investigational agents. 8.3 IRB Approval Each investigator must meet the requirements of the Federal regulations for Protection of Human Subjects, and Informed Consent, and IRB Review and Approval (45 CFR 46: http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html and 21 CFR 50 and 56: http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr50_01.html. Also see Section 12.1.1 and Section 12.1.2). Except for Cooperative Group and CTEP funded Consortium protocols, each protocol must have documentation of IRB approval prior to CTEP approval. Evidence of IRB approval may be submitted to CTEP at any time in the review process. If multiple institutional IRBs are involved, only the approval from the Coordinating Center need be submitted for CTEP records; of course, each investigator must meet Federal regulations for informed consent and IRB review (45 CFR 46 and 21 CFR 50 and 56). Section 8 - Investigator’s Manual 2009 40
Investigators’ failure to submit evidence of IRB approval is a major cause of delay in protocol approval. The documentation requirements are satisfied by completion of Form 310, or by a letter specifying: • The study title • The protocol chair and the institution's assurance number; i.e., the assurance number issued by the OHRP, DHHS • Date of IRB review • The dated signature of an institutional official, usually the IRB chair. 8.4 Protocol Review CTEP must review and approve every protocol involving CTEP-supplied investigational agents or studies receiving NCI support or funding. We review each protocol for completeness, scientific merit, duplication of existing studies, patient safety, and adequacy of regulatory and human subjects protective aspects. CTEP will inform the protocol source if the protocol is incomplete, or the investigator/institution is ineligible under the proposed category of sponsorship. CTEP will not review the study for scientific content. 8.4.1 Scheduling the Protocol for Review The PIO schedules the protocol for review by the Protocol Review Committee (PRC). The cutoff date for protocol receipt is Tuesday at 5 pm. Protocols that are complete and eligible are abstracted into the CTEP system and scheduled for review within four weeks. 8.4.2 Review by the CTEP Protocol Review Committee The CTEP PRC reviews all protocols. This committee, composed of CTEP’s professional staff and consultants from other NCI divisions, and chaired by the Associate Director, CTEP, meets weekly and usually reviews 10 to 20 documents (protocols, LOIs and concepts) at each session. Each protocol is assigned a minimum of five reviewers; as many as six to seven may be required for complex multimodality protocols. The protocol and informed consent form are reviewed by an oncologist(s), biostatistician, pharmacist and regulatory affairs professional(s) with expertise in informed consent issues. 8.4.3 The Review of the Protocol The PRC discusses the protocol after hearing the reviews of each assigned reviewer and makes a decision that the science and safety of the study are: • Approved as written; • Approved with recommendations - CTEP asks the investigator to consider points raised in the consensus review, but the investigator is not obligated to revise the study. If changes are made prior to activation of the study, the investigator must send CTEP an activation amendment that details any changes in the CTEPapproved document; • Approval deferred pending revisions - The PRC has significant questions about the proposed study. It cannot be accepted unless the investigators satisfactorily address the concerns of the written consensus review. The investigator should submit a revised protocol within two weeks of receipt of the consensus review (Section 8.4.7); Section 8 - Investigator’s Manual 2009 41
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: consent forms. However, the informe
Page 49 and 50: espond to this re-review in the sam
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
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• Agent preparations must be perf
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Procedure for Acute Exposure or Spi
Page 101 and 102:
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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