1. Safety Associates
1.1. Verbal
1.1.1. Reviews clinical safety and safety data data
1.1.2. Communicates any adverse events from study subjects
1.2. Written
1.2.1. Reporting any adverse events
2. Biostatistician
2.1. Verbal
2.1.1. Reviews accrual rates and adverse events of study subjects
2.1.2. Communicates if trial needs to be put on hold, or discontinued, or completed early based on data
2.2. Written
2.2.1. Report accrual rate and adverse events of study subjects
3. Data Safety Monitoring Board
3.1. Verbal
3.1.1. Advises on how to conduct trials that have potentially harmful effects to study subject
3.2. Written
3.2.1. Report any adverse events
4. Medical Writer
4.1. Written
4.1.1. Provides the writing multiple of documents, such a Clinical Protocols, Consent Forms, Investigator’s Brochures, Final Reports, product inserts and publications.
5. Clinical Reseach Assisant
5.1. Verbal
5.1.1. Reviews trial with CRC as assisant
5.1.2. Delegate tasks to
5.2. Written
5.2.1. Prepares study documents
6. Data Manager
6.1. Verbal
6.1.1. Reviews study subjects health records
6.1.2. Address and Data queries and follow up with data due dates
6.2. Written
6.2.1. Submit study subjects health record
6.2.2. Submit data from trial
7. Research Pharmacist
7.1. Verbal
7.1.1. Communicates unbinding information when appropriate
7.1.2. Provides information about study drug
7.2. Written
7.2.1. Maintains appropriate documentation regarding study drug
8. Clinical Research Associate (CRA)
8.1. Verbal
8.1.1. Helps Set-up Study Lab
8.1.2. Reviews Trial Protocol
8.1.3. Contact for Study Manager and Sponsors
8.2. Written
8.2.1. Ensures correct documentations are in order to run trial
9. Study Manager
9.1. Verbal
9.1.1. Explains Overall Purpose of Trial
9.1.2. Helps troubleshoot any issues that may arise
9.2. Written
9.2.1. Employment Agreement
10. Study Monitor
10.1. Verbal
10.1.1. Reviews/Discusses Trial Data
10.1.2. Reviews Protocol to Ensure Data Accuracy
10.2. Written
10.2.1. Sends and Receives Trial Data
11. Regulatory Affairs Associate
11.1. Verbal
11.1.1. Contact for Health Canada and FDA
11.1.2. Explains all necessary regulates from Heath Canada/FDA
11.2. Written
11.2.1. Ensures appropriate Health Canada/FDA documentations are completed and submitted
12. Research Nurse
12.1. Verbal
12.1.1. Informs about study subjects health
12.2. Written
12.2.1. Provides health assessment of study subjects
13. Research Ethics Board
13.1. Verbal
13.1.1. Provides Eithical and ICH-GCP information
13.2. Written
13.2.1. Collects necessary regulation/consent documents