Useful Links to External Sources

Clinical Research Terminology & Guidelines

• ICH Good Clinical Practice Guidelines
  This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process.
• NCI - Common Terminology Criteria for Adverse Events (CTCAE)
  CTCAE is widely accepted throughout the oncology research community as the standard grading scale for adverse events. You can find here the NCI repository for all CTCAE v4.0 related documents including PDF, Microsoft Excel and OWL formats.
• MedDRA - Medical Dictionary for Regulatory Activities
  MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).
• FACIT - Functional Assessment of Chronic Illness Therapy
  The FACIT Measurement System is a collection of QOL questionnaires targeted to the management of chronic illness.

Useful Links to Clinical Trials Information

• clinicaltrials.gov
  A service of the U.S. National Institute of Health, ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. ClinicalTrials.gov is a web-based resource that provides easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The website is maintained by the National Library of Medicine (NLM) at the National Institute of Health (NIH).
• EU Clinical Trials Register
  The EU Clinical Trials Register website contains information on interventional clinical trials on medicines. The information available dates from 1 May 2004 when national medicine regulatory authorities began populating the EudraCT database, the application that is used by national medicine regulatory authorities to enter clinical trial data. The EU Clinical Trials Register website launched on 22 March 2011 enables users to search for information which has been included in the EudraCT database.
• International Clinical Trials Registry Platform
  The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This aims to improve research transparency and ultimately strengthen the validity and value of the scientific evidence base.
• CenterWatch
  CenterWatch offers several services and resources specifically to patients. The Clinical Trial Listing Service provides patients unbiased information on clinical trials, with a clinical trial database of currently enrolling trials. Information on drugs and new medical therapies are available. CenterWatch also provides patients with health and educational resources about clinical trials and other health information.
• EudraCT
  EudraCT is a database of all clinical trials commencing in the EU community from 1 May 2004 onwards. It has been established in accordance with Directive '2001/20/EC'. This site is the sponsor and Paediatric Investigation Plan addressee (PIP addressee) interface which gives these groups access to the EudraCT application.