Risk management planning should take as much priority as project planning . The goal is to assure that the study is carried out correctly so that the outcomes are reliable and valid, and participants are safe. Plans will be put in place for monitoring participant safety and reporting safety data according to sponsor, ethics committee and regulatory authories
Any risks to the safety of patients and those who carry out the study, and to the integrity of the data should be identified in advance where possible so they may be mitigated.
Data collected during the study must be reliably and correctly gathered, carefully entered into the appropriate clinical record form and safely secured. If that is not done, the study cannot fulfill its purpose.
Data management plan
Good data management practices are key to the success of a clinical trial so we have included tools to help with the development of data management plans, and the selection & design of an appopriate database and data capturing instrument (case record form, CRF) that suits the objectives of your trial.
To help investigators implement the Malaria Therapeutic Area Data Standard (TAUG-malaria) (link is external)developed in partnership with CDISC we are delighted to share a standardised CRF within the Toolkit, which facilitates the collection of relevant clinical data according to CDASH (Clinical Data Acquisition Standards Harmonization) standards and will map the data to the SDTM (Study Data Tabulation Model). Our CDASH compliant CRF is intended to be used by those involved in the planning, collection, management and analysis of antimalarial clinical trials and clinical studies to ensure compliance to relevant regulatory requirements for submission. We also hope it will promote data interchange allowing data to be pooled and shared, and ensure that clinical malaria data is appropriately archived and available for further analysis and reporting.
Think of quality control procedures, including how you will ensure data completeness. And checks on instruments and human procedures - for example, how will the quality of microscopic counting of malaria parasites in blood samples be assured? Consider use of electronic versus paper data capturing methods. All of these should aim to ensure clean and accurate data as per the protocol.
The decision about which data management system to use will depend on its cost and complexity; choose one that fits the expertise within your institution, is cost-effective and suits the study needs. If needed, we have developed a freely-available REDCap template database compatible with our template CRF - please see our information sheet for details of how to access this.