20 February 2006

Requirements for investigators

An investigator should be properly qualified for the responsibility, be familiar with the product and protocol, and be willing to comply with regulatory authorities.

An investigator should have sound knowledge of the following:
a. The declaration of Helsinki.
b. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) guidelines.
c. Good Clinical Practice (GCP) guidelines and South African GCP guidelines.
d. FDA (Food and Drug Administration) regulations.

An investigator should also:

  • Be properly qualified for the responsibility.
  • Be familiar with the product and protocol.
  • Be willing to comply with regulatory authorities.
  • Have adequate time and resources to do the trial.
  • Be willing to take the responsibility for the patient.
  • Be willing to take the responsibility for the storage and accountability of the investigational product (new drug).
  • Assure accuracy, completeness, legibility and timeliness of the data.
  • Be willing to archive the data for up to 15 years.

Bets Breedt, MBChB, B Med Sci, M Fam Med
Manager Investigator Services: Quintiles

1. Code of Federal regulations.
2. International Conference on Harmonisation guidelines.
3. Ken Flieger. Testing drugs in people. FDA Consumer July-August 1994.
4. Joanne Kabak. Clinical Trials: How drugs get from the test tubes to us.
5. T.A.M. Kramer. Drug Development. Medscape Psychiatry & Mental Health eJournal, 24 July 2002.


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