tr • en

Research planning

Medical research planning

Clinical trials and observational studies

During the planning phase of the research study, the documents listed below are prepared in line with the SOPs of the sponsor or the organization, in close contact with the Project Manager / Principal or Coordinator Investigator. The drafts are presented to the Project Manager and/or investigator, and revised according to the comments until final documents are achieved.

The following services are provided for this phase:

  • Preparation and review of
    • Synopsis
    • Protocol preparing
    • Case Report Form (CRF) / Data Collection Form (DCF)
    • Informed Consent Form (ICF)
  • Sample size calculation

Preparation of Ethics Committee submission files

Upon designation of the participating investigators/centers, KAPPA delivers the investigators and sponsors a list of the documents they will be required to prepare / provide for the Ethics Committee submission. When all necessary documents are provided to KAPPA, the submission files are prepared. KAPPA is responsible of fulfilling all revision requests, delivery of revised files to investigators / sponsors, and the ongoing revisions until approval is obtained.

Services provided within this framework are as follows:

  • Ethics Committee (EC) master file preparation
  • Review of the file prepared by the investigator in case of investigator-initiated studies

Reporting research findings

The following services are provided to present the results obtained during and after the study:

  • Interim study report preparation
  • Final study report preparation