1. Chicken Soup for the Busy Coordinator July 2009

2. Question: My trial has completed and we are preparing for closure of study. How long do we need to archive all the Medical Records and Essential Documents for? Tip Of The Month

3. Answer: 1.For Clinical Trials, Medical Records and Essential Documents should be kept for: At least 2 years after the last approval of a marketing application and until there are no pending or contemplated marketing applications, or At least 2 years after the formal discontinuation of clinical development of the Investigational Product, or 6 years after completion of the clinical trial. 2.For all Other Research, the documents should be retained for at least 3 years after completion of the research study.

4. References: Singapore Guideline for Good Clinical Practice section 4.9.6 - Records and Reports NHG Proper Conduct of Research SOP 501- B05 – Documentation Link Link

5. Contributed By Christine Tioh Research Nurse Clinical Research Unit Alexandra Hospital

6. Your feedback is important to us. Feel free to write to us through: Email: crcs@nhg.com.sg Snail mail: Clinical Research Coordinator Society (CRCS) c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore 149547 For More Information