Data Management Protocol: Blueprint To Stamp Good Data Management Procedures. Experience from a multicountry study in East and South Africa
Abstract accepted as oral presentation on the 9th European Congress of Tropical Medicine and International Health, Basel, 2015
Mary Thiongo(1), Harry van Loen(2), Gilles Ndanyisaba(3), Linh Diep(4), Raffaella Ravinetto(2,5), Liselotte Hardy(2), Peter Gichangi(1)
(1)International Centre for Reproductive Health, Kenya
(2)Institute of Tropical Medicine (ITM) Antwerp, Belgium
(3)Rinda Ubuzima, Rwanda
(4)WITS Reproductive Health and HIV institute, South Africa
(5)Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium
A Clinical Data Management Protocol (DMP) describes the data management (DM) processes, systems and responsibilities in a clinical study. We will describe how its implementation in the study ‘Characterization of Novel Microbicide Safety Biomarkers in East and South Africa’ was coordinated with a capacity building initiative.
This multicountry study, funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) and sponsored by the International Centre for Reproductive Health (ICRH), was carried out at the WITS Reproductive Health and HIV Institute in South Africa (WRHI), Rinda Ubuzima (RU) in Rwanda and at the ICRH in Kenya. The Institute of Tropical Medicine (ITM) in Belgium was a collaborating partner. Partner data managers met with an objective of sharing best practices, to build and strengthen the implementation:: the WRHI data manager wrote the DMP, ICRHK designed the database and trained data-entry staff, RU designed the DM study documentation, while ITM provided coordination, training and ongoing remote support.
The DMP guided the study on the following:design of the case report form, database development, procedures/timelines, data quality control, training, roles and responsibilities and communication flow. Adherence to the DMP ensured standardizing and harmonizing and it promoted timely communication across the research teams, resulting in coordination of key-activities such as data review/cleaning. The DMP became a useful reference for monitors during their monitoring visits to the sites. Concomitantly, the capacity building plan contributed to innovation of local capacity by enhancing skills in database design,validation and documentation.
A DMP is an essential document that guides the DM process likewise a study protocol guides the study procedures. When working in low-income settings and/or in new research sites, the DMP should envisage a capacity building component, to strenghten local capacity.