Data Management in Clinical Research course, Malawi
Course title: DATA MANAGEMENT IN CLINICAL RESEARCH
DATE: 9-12th July 2019
LOCATION: Blantyre Health Research and Training Trust, BHRTT (Malawi)
N.º HOURS: 25h
COORDINATION: Blantyre Health Research and Training Trust, BHRTT (Malawi)
SUPPORTING ORGANIZATIONS: CISM, ISGLOBAL, ECRIN
1. SCOPE OF THE TRAINING:
Data Management in clinical trials is critical to the success of providing evidence. The compliance with the recommendations provided in the Good Clinical Practice Guidelines (ICH-GCP – E6(R2)) assures the quality of the data collected throughout the clinical trial. To achieve the recommended levels of quality in the conduction of clinical trials, data management professionals should have training about all the strategies and procedures to comply with.
Clinical Trial Data management requires abilities in: data planning (creating data bases and data collection), data processing and analyzing, data management systems (hardware and software), data protection and storage (safety and secure), data transfer (ethics and regulations), data quality control and assurance.
The syllabus for this course was prepared according to the TESA members needs in Data Management, after filling a survey (December 2018-January 2019). In this survey the 28 respondents rated as Not relevant, Relevant or Very Relevant each of the topics covered in this course. All topics were rated by the majority as Relevant or Very Relevant. The topics with higher number of “Very Relevant” rating were chosen to be covered in more detail and with an extended practical approach.
This short-term training course aims at promoting professional development and scientific leadership in clinical trials within TESA Network, specifically in data management, with a practical approach.
With this course it is expected that the participants bring the knowledge and practical approaches to the respective institutions.
Therefore, at the end of this training course the students will be able to:
Adapt and operate an existent CRF for clinical trial data collection
Plan data management procedures for a clinical trial
List the topics and concepts to be considered in a Statistic plan in a Clinical Trial Protocol
Propose one or more clinical trial data archiving strategies
Discuss the relevance of Data Sharing
Recognize the need for Multimodal Data Management
Support the development of a Data Management Center in the respective institution
3. LEARNING AND EVALUATION METHODOLOGY:
A certificate will be given to each student that attended to the course and participated in all the practical sessions. A short quiz will be given to the students at the end of each module to confirm that the main concepts were acquired.
4. QUALITY OF THE TRAINING AND EVALUATION:
At the end of the course a questionnaire will be given to each student to register their degree of satisfactions about the course.
5. TARGET STUDENTS:
Professionals from organizations from all TESA members working in Projects involving Clinical Trials
Data Management and/or Data Management Centres