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Policies & Procedures of the CTN

These guidelines explain the policies and procedures of the National Drug Abuse Treatment Clinical Trials Network (CTN). Some of these guidelines reflect Department of Health and Human Service requirements for federally funded clinical research while others are the result of a consensus among NIDA staff, the CTN Steering Committee, and qualified extramural clinical investigators. These guidelines have been updated to reflect current practices. Although further evolution of these guidelines is inevitable, it is hoped that the codification of NIDA CTN policies and procedures will continue to encourage a research philosophy and discipline that will produce consistently excellent clinical trials that will ultimately improve the treatment of drug addiction in the United States.

Acronyms of CTN terms

Our policy and procedure information materials are provided in PDF format. In order to view the file, you will need Adobe Acrobat Reader.

If you have the Acrobat reader plug-in for Netscape or Internet Explorer click on the document links below and you will be able to view and/or print out the pages. If you do not have the plug-in, you will need to download the document to your hard drive.

The Reader can be downloaded for free from www.adobe.com.

POLICIES

Policy Number

Title

CTN-POL-002

Steering Committee & Structure

CTN-POL-003

Conflict of Interest

CTN-POL-004

CTN as a Platform

CTN-POL-008

Common Assessment Battery

CTN-POL-009

Safety

CTN-POL-010

Publications Policy

CTN-POL-011

Concept Generation

CTN-POL-012

Protocol Review Board

CTN-POL-013

Training

CTN-POL-014

QA Policy

CTN-POL-015

Regulatory Affairs

CTN-POL-016

Data Management & Design

CTN-POL-017

Protocol Amendments

CTN-POL-018

DSMB Policy

CTN-POL-019

Authorization for Protocol Initiation

CTN-POL-020

CTP Participation in Protocols

CTN-POL-021

D&A Charter

CTN-POL-022

Minority Participation in Protocols

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PROCEDURES
Procedure Number

Title

SOP-DA-001

D&A Recommendations

SOP-GN-002

Parliamentary Procedures

SOP-GN-004

Budget Guidelines

SOP-GN-005

Communication Guidelines

SOP-GN-007

How to Prepare a SOP

SOP-PR-001

Concept Submission

SOP-PR-002

Protocol Project Organization

SOP-PR_002b

Project Task List

SOP-PR-003

Protocol Development

SOP-PR-004

Protocol Template

SOP-PR-006

LI Report

SOP-PU-001

Publications

SOP-QA-001

QA Plan Required Elements

SOP-QA-002a

Project Initiation Checklist (Node)

SOP-QA-002b

Project Initiation Checklist (CTP)

SOP-QA-004a

QA Interim Report Template

SOP-QA-004b

QA Interim Report Template (Instructions)

SOP-QA-005

QA Information Flow

SOP-RA-002 Certificate of Confidentiality
SOP-SF-001

Safety Procedures

SOP-SF-002

SAE Flow Chart

 

 
 

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The National Institute on Drug Abuse (NIDA) is part of the National Institutes of Health (NIH), a component of the U.S. Department of Health and Human Services. Questions? See our Contact Information. Last updated on Friday, May 21, 2004.