Pharma Sector Work plan for 2015

Action for SACRA for 2015

  1. SACRA to have a reference document on website on TransCelerate.

  2. Work on a response to the MCC inspectorate about safety detection, with a focus on 100% source review at minimum and SDV as per monitoring plan.

  3. CRA Training:

  • SACRA to organise generic trainings such as how to interpret an ECG, how to review a lab report. The lab training should be the first to be prioritised.

  • SACRA to look into a possibility of partnering with institutions such as WITS for them to provide therapeutic area training when needed.

  • Managers need to commit to ensuring that CRAs attend SACRA because this is where they can gain knowledge without reading, also encourage medical advisors to get involved in SACRA

  • SACRA meetings and AGENDA needs to be publicised on time, at least a month ahead of time to see if that cannot boost CRA attendance of these meetings.

  • SACRA to work on a feedback questionnaire that can be sent to sites for CRA performance assessment Unit Standards to be revived.

  • SACRA to ensure that the different regulations are loaded on the website as they become published

  1. Export Permits: Propose to the MCC to provide the export permit for the duration of the study

  2. Regulatory tracking. SACRA to work towards getting more companies to respond to the call for regulatory tracking. Maybe re-look at how this is done/advertised.

  3. Regulatory tracking. Not many companies respond to SACRA request to complete the online survey. That makes the data not very credible as it does not represent the many companies that do clinical trials in the country. Some people did not complete the tracker because they did not have a backblock. That might be a one of the reasons why other companies are not completing. Message to be clear to all members that they need to complete the survey that will be accessed on the SACRA website with each company having their personalised log-in details. One person per company is to be responsible for the compiling and filling in all Submission data on their company account as well as returning to update it once there is some development of the study.​