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

9 Ordering Investigational Agents from NCI .................................................................45
9.1 How to Place Agent Orders.......................................................................................45
9.2 Particular Points to Note............................................................................................45
9.3 Routing of Agent Requests .......................................................................................46
9.4 Affiliates and Agent Orders .......................................................................................46
9.5 Requests for Nonresearch (Treatment) Use of Investigational Agents .....................47
9.6 Requests for Nonclinical (Laboratory) Use of Investigational Agents........................47
9.7 Status of Investigational Agents Following FDA Marketing Approval........................47
10 Responsibility for Reporting Results to CTEP..........................................................48
10.1 Introduction................................................................................................................48
10.2 Report Requirements of CTEP Supported Trials ......................................................48
10.2.1 Clinical Trials Monitoring Service (CTMS) .....................................................48
10.2.2 Clinical Data Update System (CDUS) ...........................................................49
10.2.3 Adverse Events..............................................................................................50
10.2.4 Study Status ..................................................................................................50
10.2.5 Amendments..................................................................................................50
10.2.6 Publications ...................................................................................................50
10.2.7 Inventions ......................................................................................................50
10.3 Record Retention ......................................................................................................51
10.4 Reporting to IRBs ......................................................................................................51
11 Adverse Events.................................................................................................................52
11.1 Expedited Reporting of Adverse Events....................................................................53
11.2 Expedited Adverse Events with Commercially Available (Non-Investigational)
Agents .......................................................................................................................53
11.3 Routine Reporting of Adverse Events .........................Error! Bookmark not defined.
12 The Investigator and Protocol Chair: Roles and Responsibilities ......................54
12.1 The Investigator.........................................................................................................54
12.1.1 The FDA Form 1572......................................................................................54
12.1.2 Responsibilities of an Investigator for Human Subjects Protection ...............55
12.2 The Protocol Chair ....................................................................................................55
12.2.1 Responsibilities..............................................................................................55
12.2.2 Who May Serve as a Protocol Chair..............................................................56
13 Affiliate Investigators .............................................................................................57
13.1 Affiliate Investigators Definition .................................................................................57
13.2 Requirements of an Affiliate Investigator...................................................................57
13.3 Responsibilities of Affiliate Investigators ...................................................................57
Table of Contents - Investigator’s Manual 2009
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