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

More documents

Recommendations

Info

8.8 Reactivation of Studies Protocols that are temporarily closed require written CTEP approval before reactivation if they are: • Temporarily closed for reasons of patient safety or regulatory issues; or • Closed for reasons of peer review, site visit, or other NCI-initiated reasons. Protocols that are temporarily closed to accrual by the clinical site based on early stopping rules do not require CTEP approval for reactivation. Section 8 - Investigator’s Manual 2009 44
9 Ordering Investigational Agents from NCI • The DCTD/CTEP will provide study agents for use in CTEP-approved protocols, Special Exception and Treatment Referral Center (TRC) requests (see Section 17.1 and Section 17.2) to registered investigators who have current FDA 1572, Supplemental Investigator Data, and Financial Disclosure Forms, http://ctep.cancer.gov/forms/index.html, and CVs on file with PMB (see Section 12.1). Unless the protocol is conducted by an NCI Cooperative Group, the PMB will not send agents to assistant investigators who are not named on the protocol or who have not filed a FDA Form 1572. • Sites will only use study agents supplied by DCTD to treat patients entered onto CTEP-approved protocols for which the DCTD has agreed to supply agent. 9.1 How to Place Agent Orders • Complete the following information on the Clinical Drug Request Form NIH-986, http://ctep.cancer.gov/forms/index.html: o Investigator name and NCI-assigned investigator number o Telephone and fax numbers, and e-mail address of investigator and/or individual preparing form o o o o NCI-assigned protocol number NSC number, current inventory as indicated on Drug Accountability Record Form (DARF), agent name, strength and dose form, and quantity requested The patient ID code and initials (if the protocol is blinded) Date and signature of the investigator or designee. No matter who may be delegated to sign this form (e.g. the pharmacist), the investigator remains responsible for the disposition of all investigational agent shipped under his or her name • Note the following also: o Only one agent may be entered on each line on the form o If the same agent is needed for more than one protocol , use a separate line for each protocol o Indicate the one official shipping address to which the agent is to be sent o Submit orders to the Pharmaceutical Management Branch (PMB) by fax at 301-480-4612 9.2 Particular Points to Note • Complete the Clinical Drug Request form in full, typing all information. PMB will return incomplete and illegible forms to the originator. • Use the Clinical Drug Request for all clinical agent requests, including those for Special Exception and TRC use. • Normal PMB processing time for open label studies is two (2) working days. PMB will ship orders within two working days, based on the agent’s availability and provided there are no shipping restrictions (e.g. holidays, or thermolabile agents that are shipped Monday through Thursday only. Sites can make special arrangements for Saturday delivery by contacting PMB after faxing). Refer to individual protocols for specific ordering instructions. • Generally allow one week for order delivery. • Do not order more than a 2-month supply at a time. Section 9 - Investigator’s Manual 2009 45
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 and 48: Investigators’ failure to submit
Page 49: espond to this re-review in the sam
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
Page 99 and 100: Procedure for Acute Exposure or Spi
Page 101 and 102:
Appendix VIII National Cancer Insti
Page 103 and 104:
7) Investigational Drug Accountabil
Page 105 and 106:
• Write treatment instructions cl
Page 107 and 108:
• For agent admixtures that can b
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?