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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.
 

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