‘Overcoming the challenges of Clinical Data Management in low and middle income countries: A context-adapted Data Management Plan and Lifecycle’
Abstract accepted as oral presentation, ASTMH conference in New Orleans, 2014
Yves Claeys, James Smedley, Anish Bhattarai, Hercule Kalonji, Paritosh Malaviya, Robert Meester, David Mwakazanga, Martin Omello, Sayouba, Ouedraogo, Sopheak Sok, Sun Sokleng, Mary Thiongo, Hiwot Tilahun, Arouna Woukeu, Harry van Loen, Brian Faragher, Raffaella Ravinetto
More and more non-commercial clinical research is carried out on a collaborative basis in resource-limited contexts to address priority health problems in low and middle income countries (LMICs).
Despite the existence of FDA- and ICH-GCP guidelines for clinical research, there is a need for a practical approach in all processes including clinical Data Management (DM) to facilitate the collection and analysis of high-quality data, despite the contextual and financial constraints. Since 2010, the members of the Association for Data Management In the Tropics (ADMIT:https://admit.tghn.org) share knowledge and tackle common issues experienced like standardization, Electronic Data Capture and Data sharing.
One of the first initiatives for ADMIT was to tackle the need for uniformity in terms of context-adapted standard operating procedures (SOPs).We defined the essential DM processes within a research project. The members of the network were assigned authorship to prepare two SOPs which were presented and peer reviewed during a workshop within the wider group. A harmonisation process was undertaken to ensure uniform structure, terminology and the level of detail across the suite of SOPs.
During the harmonization, the alignment of the individual processes inspired the creation of an overall lifecycle for DM. As a result, a usable Data Management Plan (DMP) is now available incorporating the suite of these SOP’s
(In the oral presentation,) We will present the characteristics of this DMP and describe how it may help with collaborations on non-commercial research projects where DM processes are spread across different places. We recommend the DMP to be used to ensure a uniform approach to DM, strengthening partnerships and knowledge exchange. We hope that this may be a starting point for standardisation in DM in LMICs and possibly to formulate practical recommendations for regulatory and GCP guidelines.
The next challenge is to look at the definition of the roles and responsibilities needed to resource these DM activities and the development of training packages.