• http://www.vam.org.uk

• http://www.ich.org

• Good Clinical Practice: Consolidated Guidance.

• Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

• Structure and Content of Clinical Study Reports.

FDA GCP Regulations

• http://www.fda.gov/

• 21 CFR Part 50 -Protection of Human Subjects.

• 21 CFR Part 56 - Institutional Review Boards.

• 21 CFR Part 312 - Investigational New Drug Application.

• 21 CFR Part 314 - Application for FDA Approval to Market a New Drug (NDA).

• 21 CRF Part 320 - Bioavailability and Bioequivalence Requirements.

• 21 CFR Part 812 - Investigational Device Exemptions.

• 21 CFR Part 361 - Prescription Drugs For Human Use Generally Recognized As Safe.

•  And Effective And Not Misbranded: Drugs Used in Research (Radioactive Drugs).

• 21 CFR Part 54 - Financial Disclosure by Clinical Investigators.

• 21 CFR Part 11 - Electronic Records; Electronic Signatures.

FDA GCP Guidelines:

• FDA Institutional Review Board & Clinical Investigator Information Sheets.

• Guideline for Monitoring Clinical Investigations.

• Guideline for the Preparation of Investigational Drug Products.

• Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products.

PHARMACEUTICAL RESOURCES

http://www.philadelphia.edu.jo/pharmacy/resources.html

IFCC

http://www.ifcc.org/ifcc.asp