The Planning Stage of Clinical or Observational Research

At the planning stage, the documents listed below are prepared in accordance with the SOP's of the sponsor or institute (if there is one) and in cooperation with the project supervisor and/or coordinator/investigator. These documents as first drafts are then passed on to those project supervisors and/or investigators who may ask for some revisions/modifications. The appositeness of these changes are then debated and the final changes are implemented after these discussions.

• Protocol and protocol synopsis preparation
• Protocol review
• Case Report Form (CRF) / Data Collecting Form (DCF) preparation
• CRF/DCF review
• Informed Consent Form (ICF) preparation
• Sample size calculation
• Study logo design

 Preparation of Local / Central Ethics Committee Submission File

After determining the researchers/centers that will be involved with the project, KAPPA gives to the researchers and the sponsors the list of documents which must be supplied by them for the Ethics Committee application file.Once all of the requested documents are provided, the files are prepared and sent over to the researchers within 10 (ten) working days. KAPPA remains responsible for carrying out additional revisions requested by local or central ethics committees. After these revisions are made, the files are sent back to the researchers and the process of revision-submission goes on until the application is accepted and the file is approved by the Central Ethics Committee. If requested, KAPPA can also present the file to the Ethics Committee and follow closely the decision process.

Services given in this regard are:

• Preparation of the Ethics Committee (EC) master file
• Preparation of an Ethics Committee file for each center in multi-center studies
• Review of the file prepared by the researcher for research support projects
• Revision of the file prepared by the investigator
• Application to the ECs and follow up

 The Reporting of Research Results

The following services are given for the presentation of results obtained during and at the end of the study:

• Interim study report preparation
• Final study report preparation