Title: Real-time source document verification improves the quality of data management in HIV clinical trials.
Authors: Oratai Butterworth, BNS., MA.,1 Patsamon Reksirikul, BSc, MSc.,1 Kanittha Pongjit, BPharm., MSc.,1 Suwapit Prasertthanawut, B.Pharm.,1 Tulathip Suwanlerk, BNS.,1 Thidarat Jupimai, BSc., MSc.,1 Jiratchaya Wongsabut, BSc., MSc.,1 Anchalee Avihingsanon, MD., PhD.1,2 and Jintanat Ananworanich, MD., PhD.,1,2,3.
Institution affiliation:.
1The HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand.
2 Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand .
3 SEARCH, the Thai Red Cross AIDS Research Centre Bangkok, Thailand.
Author for correspondence: Oratai Butterworth, The HIV Netherlands Australia Thailand Research Collaboration, 104 Ratchadumri road, Pathumwan, 10330, Bangkok, Thailand.
Email: oratai.b@hivnat.org.
Source of funding: The HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand.
425 words allowed (will review the abstracts after the MS is done). .
Background: Source document verification (SDV) is an important procedure for maintaining the quality of clinical trials. Real-time instead of periodic source document verification could significantly improve the quality of data captured in HIV clinical trials. .
Purpose: To evaluate real time monitoring could lead to improve the data quality.
Method: In addition to periodic source document verification by the clinical research associates, The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), research center in Bangkok formed an internal monitoring group in March 2012 to conduct real-time SDV within 14 days from the study visit date. SDV includes verifications of protocol adherence, signed consent forms, serious adverse events reports and protocol deviations and transcriptions in case record forms. Feedback was given to the study nurse immediately after finish monitoring and every three month to the study team.
