Study Planning/set-up activities
 When required, assist LTM to conduct site feasibility 
 conduct Pre-trial visits to assess the investigational staff and facilities
 Discuss the items listed on the PAR with the investigator and other appropriate staff
 Review the site commitment in detail with the investigator
 Develop/adapt recruitment and retention strategy for the site
 Ensure all required trial-related materials and supplies are provided to the investigational site
 Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
 Set up the IF and TCF
 If needed, development of site-specific ICF
 Ensure that the investigational staff are instructed on the requirements for proper informed consent
 When local Ethics Committees are used, ensure that the IEC/IRB is provided with current and complete copies of all documents that the IEC/IRB requests to fulfill its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB
 Obtain site related trial documents and review them for completeness and accuracy
 Negotiate investigator budgets at site level and track the status of site CTA
 Plan and conduct investigator and site-staff training
 Conduct site initiation visits
 If applicable, execute the user acceptance testing plan
 If applicable, create site specific and monitoring tools

Monitoring activities
 Notify the GTM and the Local CSC in writing, when a country and an investigational site is approved to receive clinical drug supplies
 At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g , temperature logs, security), and returned, accurately inventoried and documented. Inform the investigational staff of the distribution process
 Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
 Report to LTM on study site status through monitoring report and meetings
 Document all study related communications
 Perform SDV to ensure accurate data is recorded based if required
 Follow up with the trial site(s) regarding completion of case report forms and data correction forms within required timeframe 
 Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate. For AEs/SAEs ensure they are consistent with all data collected and with the information in the source documents
 Ensure that the investigators send the safety reports to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB