advertisement
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.

0
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

References:
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. Drkoop.com:Family:Features
5. T.A.M. Kramer. Drug Development. Medscape Psychiatry & Mental Health eJournal, 24 July 2002.

 
NEXT ON HEALTH24X
advertisement

Read Health24’s Comments Policy

Comment on this story
0 comments
Comments have been closed for this article.

Live healthier

Wasting water? »

South Africa is facing a water crisis Water saving tips Water quality report shocks

SEE: How much water do you use per day?

With level 4 water restrictions in Cape Town, residents are urged to use a maximum of 100 litres per person per day. Here’s how quickly it adds up.

Life saving tip! »

SEE: 10 things to keep in your first aid kit 10 first aid myths

Here's why you need a first aid kit in the car

Emergency services are often spread thin, especially when storms and major disasters strike. When travelling on the road, having a well-stocked first aid kit could be a lifesaver.