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Protocol Template

Protocol Template

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University of Pennsylvania
Protocol Design Template\u00a9 2005
Trustees of the University of Pennsylvania
INSERT TITLE OF THE PROTOCOL
Regulatory Sponsor:

Insert the Name of the Sponsor-Investigator
Insert Department Name
Insert Address
Insert Phone Number

Funding Sponsor:
Insert the Name of Primary Funding Institution
Insert Address
Insert Phone Number
Study Product:
Insert Study Drug Name \u2013 Generic, followed by marketed
name if applicable
Protocol Number:
Insert Protocol Number Used by Sponsor
IND Number:
Insert IND Number if applicable

Date:
Amended:
Administrative Change:

CONFIDENTIAL

This document is confidential and the property of the University of Pennsylvania. No part
of it may be transmitted, reproduced, published, or used by other persons without prior
written authorization from the study sponsor.

Page ii
Table of Contents
STUDY SUMMARY....................................................................................................................................................1
1 INTRODUCTION......................................................................................................................................................2

1.1 BACKGROUND...........................................................................................................................................................2 1.2 INVESTIGATIONAL AGENT...........................................................................................................................................2 1.3 PRECLINICAL DATA...................................................................................................................................................2 1.4 CLINICAL DATA TO DATE...........................................................................................................................................2 1.5 DOSE RATIONALE AND RISK/BENEFITS........................................................................................................................2

2 STUDY OBJECTIVES..............................................................................................................................................2
3 STUDY DESIGN........................................................................................................................................................2

3.1 GENERAL DESIGN.....................................................................................................................................................2 3.2 PRIMARY STUDY ENDPOINTS......................................................................................................................................2 3.3 SECONDARY STUDY ENDPOINTS...................................................................................................................................2 3.4 PRIMARY SAFETY ENDPOINTS.....................................................................................................................................3

4 SUBJECT SELECTION AND WITHDRAWAL....................................................................................................3

4.1 INCLUSION CRITERIA.................................................................................................................................................3 4.2 EXCLUSION CRITERIA................................................................................................................................................3 4.3 SUBJECT RECRUITMENT AND SCREENING......................................................................................................................3 4.4 EARLY WITHDRAWAL OF SUBJECTS..............................................................................................................................3

4.4.1 When and How to Withdraw Subjects..........................................................................................................3
4.4.2 Data Collection and Follow\u00adup for Withdrawn Subjects.............................................................................3
5 STUDY DRUG................................................................................................................................................... . . . . . . . .3

5.1 DESCRIPTION............................................................................................................................................................3 5.2 TREATMENT REGIMEN...............................................................................................................................................3 5.3 METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS..........................................................................................3 5.4 PREPARATION AND ADMINISTRATION OF STUDY DRUG....................................................................................................3 5.5 SUBJECT COMPLIANCE MONITORING............................................................................................................................4 5.6 PRIOR AND CONCOMITANT THERAPY...........................................................................................................................4 5.7 PACKAGING..............................................................................................................................................................4 5.8 BLINDING OF STUDY DRUG........................................................................................................................................4 5.9 RECEIVING, STORAGE, DISPENSING AND RETURN...........................................................................................................4

5.9.1 Receipt of Drug Supplies..............................................................................................................................4 5.9.2 Storage..........................................................................................................................................................4 5.9.3 Dispensing of Study Drug............................................................................................................................4 5.9.4 Return or Destruction of Study Drug...........................................................................................................4

6 STUDY PROCEDURES............................................................................................................................................5

6.1 VISIT 1...................................................................................................................................................................5 6.2 VISIT 2...................................................................................................................................................................5 6.3ETC.........................................................................................................................................................................5

7 STATISTICAL PLAN................................................................................................................................................5
7.1 SAMPLE SIZE DETERMINATION....................................................................................................................................5
CONFIDENTIAL
This material is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study sponsor
Page iii
7.2 STATISTICAL METHODS..............................................................................................................................................5
7.3 SUBJECT POPULATION(S)FOR ANALYSIS.......................................................................................................................5
8 SAFETY AND ADVERSE EVENTS.......................................................................................................................5

8.1 DEFINITIONS.............................................................................................................................................................5 8.2 RECORDING OF ADVERSE EVENTS...............................................................................................................................7 8.3 REPORTING OF SERIOUS ADVERSE EVENTS...................................................................................................................8

8.3.1 Study Sponsor Notification by Investigator..................................................................................................8 8.3.2 EC/IRB Notification by Investigator............................................................................................................9 8.3.3 FDA Notification by Sponsor.......................................................................................................................9

8.4 UNBLINDING PROCEDURES..........................................................................................................................................9 8.5 STOPPING RULES................................................................................................................................ . . . . . . . . . . . . . . . . . . . . .9 8.6 MEDICAL MONITORING..............................................................................................................................................9

8.6.1 Internal Data and Safety Monitoring Board................................................................................................9
8.6.2 Independent Data and Safety Monitoring Board.........................................................................................9
9 DATA HANDLING AND RECORD KEEPING...................................................................................................10

9.1 CONFIDENTIALITY....................................................................................................................................................10 9.2 SOURCE DOCUMENTS...............................................................................................................................................10 9.3 CASE REPORT FORMS..............................................................................................................................................10 9.4 RECORDS RETENTION..............................................................................................................................................11

10 STUDY MONITORING, AUDITING, AND INSPECTING..............................................................................11
10.1 STUDY MONITORING PLAN.....................................................................................................................................11
10.2 AUDITING AND INSPECTING.....................................................................................................................................11
11 ETHICAL CONSIDERATIONS..........................................................................................................................11
12 STUDY FINANCES...............................................................................................................................................12

12.1 FUNDING SOURCE..................................................................................................................................................12 12.2 CONFLICT OF INTEREST..........................................................................................................................................12 12.3 SUBJECT STIPENDS OR PAYMENTS............................................................................................................................12

13 PUBLICATION PLAN..........................................................................................................................................12 14 REFERENCES.......................................................................................................................................................13 15 ATTACHMENTS...................................................................................................................................................13

CONFIDENTIAL
This material is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study sponsor

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