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The Office of Clinical Research is pleased to offer you the following links that might be helpful in conducting your research: General- Tri-Council Policy Statement Ethical Conduct for Research Involving Humans
[August 1998 - Updated: May 2000, September 2002] - Association of Clinical Research Professionals (ACRP)
- Bannatyne Campus Research Ethics Boards
University of Manitoba - Bioethics Resources on the Web
Other educational resources, including online tutorials, bibliographies and professional societies. - CBER Dear Gene Therapy IND Sponsor / Principal Investigator Letter
At this site you can access a letter written by CBER's director, Kathryn Zoon, to all sponsors and principal investigators of gene therapy INDs to clarify serious adverse events (SAE) reporting requirements. - Centers for Disease Control's Human Subjects Research
It helps researchers determine what should go into a protocol, how to provide safeguards for children, pregnant women and genetics research. It includes forms for IRB review, guidelines for informed consent documents, sample IRB reports, an all-day training seminar for investigators and a two-hour "nuts and bolts" education session for investigators. - CenterWatch
Clinical Trials Listing Service - ClinicalTrials.gov
The purpose of this site is to inform potential subjects about studies. It is the first comprehensive listing of federally funded trials in the United States. This site is expected to become the major online clearinghouse for private and publicly funded trials, and in the process, to help trial sites and other businesses get work, and track the industry. - Declaration of Helsinki
- FDA Code of Federal Regulations
Title 21, Volume 1 (Revised as of April 1, 2003) - FDA Disclosure - Financial Interests and Arrangements of Clinical Investigators
Form #3455 (MS Word file) - FDA Disqualified Investigator List
This is a frequently updated list of clinical investigators who have been, or are currently, disqualified from access to investigational products, or had their use of investigational products restricted. - FDA Forms Distribution Page for CDER
- FDA Guidance document and FAQs for Financial Disclosure by Clinical Investigators
- FDA information
- FDA: For Good Clinical Practice and Clinical Trial Information
- FDA's Good Clinical Practice
- Food and Drugs Act
Health Canada - Good Clinical Practice Consolidated Guideline
Published by Health Canada - Health Canada Guidance for Clinial Trial Sponsors
- Health Care Ethics Guide
Catholic Health Association of Canada - Health Care Products Association
- Health Information Privacy Committee (HIPC)
This site contains information about the committee, including: Terms of reference; Submission form; Submission deadlines; Meeting dates; Other Information - Interagency Advisory Panel on Research Ethics
Tri-Council Policy Statement review - International Conference on Harmonisation (ICH) Guidelines
GOOD CLINICAL PRACTICE (E6) As adopted by the FDA [1997] - Management Training for the Health Care Sector
- Manual of Regulatory Standard Operating Procedures and Policies
Provides two new Standard Operating Procedures and Policies to notify NIH when FDA has received adverse event reports and protocol changes. - MDS Metro Laboratory Services
- NARA - Code of Federal Regulations
- NIH Office of Extramural Research
Office for Protection from Research Risks (OPRR) - Personal Health Information Act of Manitoba (PHIA)
- Society of Clinical Research Associates (SoCRA)
- University of Minnesota - Informed Consent
Helps the user through the informed consent process itself, and helps create a sample document. Using an alogrithm, their site takes the reader through a series of questions that help the investigator / IRB design an informed consent document that ensures readability and understanding of the subject.
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