One of the MCTA centres; Kilifi, has agreed to host the course. To know more about your colleague-site, please visit: http://www.kemri-wellcome.org/. Our training partner AMANET will be running the course. For more on AMANET, please visit: http://www.amanet-trust.org/

 

The course will follow a similar programme held in Bagamoyo, Tanzania and will include topics as shown below.

 

MCTA will again offer opportunities to at most two participants from each of your sites who have not recently participated in its GCP training courses in Lambarene and Bagamoyo to attend this course.

 

If your site wishes to fund extra participants to the course, please contact us to find out whether or not this is possible. There is a limit in the total number of participants for the course

 

Please submit your nominations to me preferrably by 6 October so that we can start working on the logistics. In your nominations, please include email addresses of the nominees, and a 1-2-page biosketch indicating background and his/her work at site.

 

TOPICS

• Good Clinical Practice (GCP): A historical perspective
• From the test tube to the person: current requirements
• Who is an Investigator & what does (s)he do?
• Who/what is a sponsor?
• Role of Regulatory Authorities
• Role of IEC/NEC/IEC
• Role of the ISM & DSMB
• Basics of GLP
• Standard Operating Procedures
• Standard Operating Procedures Exercise
• Quality Control and Quality Assurance
• Informed Consent: Basis, importance & process
• Informed Consent: Content & Process Role Play
• Use of trial logs as tracking tools
• Authorised signatories and the CRF
• Handling of the study product & accountability
• When should the trial begin?
• Randomisation code & keeping the blind ting
• Essential documents
• Data Management & quality
• Safety evaluation: Adverse events and their reporting
• AE/SAE Exercises
• GCP issues in participant follow up
• Trial Communications: Internal & External
• Role of the Clinical Monitor
• Role of the site Coordinator
• Dealing with data queries
• Sponsor versus investigator insurance
• Maintaining the investigator File
• Statistical issues in the trial: Sample size, dropouts, & missing data
• Premature termination of the trial
• Confidentiality in trials
• Trials audits
• Study close out issues
• Reports: Investigator obligations
• The participants and research community