CLINICAL RESEARCH COORDINATOR

1. PRINCIPAL INVESTIGATOR

1.1. Both verbal (in person, phone) and written communication (emails, documents) regarding all aspects of the trial.

2. RESEARCH PHARMACIST

2.1. Mostly verbal communication in person regarding the dosage levels assigned to different participant groups, dose adjustments, patient compliance and ordering an adequate supply of medication/therapeutic devices to be used during the trial.

3. RESEARCH NURSE

3.1. Mostly verbal communication regarding the health assessment, monitoring of patient condition, reporting of adverse effects, data collection and overall trial conduction according to SOP.

4. DATA MANAGER

4.1. Verbal and written communication to ensure data is being collected, recorded and archived in compliance with the SOP.

5. INSTITUTIONAL REVIEW BOARD

5.1. Mostly written communication via emails and document submissions, but will also be communicating with the board during meetings at predetermined intervals throughout the trial.

6. PATIENTS

6.1. Verbal (in person and over phone) and written communication during patient recruitment, informed consent process and to answer any questions or concerns patients may have.

7. TRIAL SITE

8. TRIAL ACCOUNTS MANAGER

8.1. Mostly written communication while constructing a categorised budget for the trial, and any readjustment in the budget throughout the study.

9. CLINICAL RESEARCH ASSOCIATE

9.1. Both written and verbal  communication regarding anything to do with the trial design (changes, patient drop-out, etc) and smooth trial conduction according to SOP.

10. CLINICAL SITE MONITOR

10.1. Both written and verbal communication to coordinate site visits and resolve any site-related issues that may be non-compliant to SOP and regulatory guidelines.

11. CLINICAL TRIAL OPERATIONS MANAGER

11.1. Both written and verbal communication regarding any issues that may hinder smooth trial conduction, such as need for subject recruitment, supplies for the site, additional on-site personnel.

12. RESEARCH DATA AND REGULATORY COORDINATOR

12.1. Both written (email) and verbal (phone) communication regarding any discrepancies found on study data or any regulatory paperwork that require completion.

13. SPONSOR SITE