1. Regulatory Affairs Associates
1.1. Interaction of regulatory affairs with CRC include: -ensures all required documents are completed and filed properly by the study site - offers support for clinical trials
1.1.1. written
1.1.1.1. emails, letters, documents all should be have clear and consice messages
1.1.2. oral
1.1.2.1. face to face,, telephone calls with professional tones. no slurring or words or rude interruptions
2. Study Manager
2.1. With years of related experience, study manager oversees the trial. Help to troubleshoot with the trial.
2.1.1. Interactions can include; emails, phone calls, video chat, face to face conversations.
3. Other CRCs and CRAs
3.1. CRC/CRA are some of the main and primary contacts within clinical trials. They help set up the study site, meet with investigators and review the trials' protocol.
3.1.1. Interactions can include: verbal communications: face to face conversations, phone calls and emails non verbal: body language, facial expressions and gestures.
4. Study Monitor
4.1. Interaction of study manger with CRC include: -review data submitted by study site - ensuring compliance of study protocol
4.1.1. oral
4.1.1.1. skype, face to face, meeting and telepone
4.1.2. written
4.1.2.1. documents, faxes, emails
5. Participants
5.1. Interaction of participant with CRC include: - helping with screening participants for trials - complying with protocol of trial when gaining informed consent - Visits and follow-ups with participants throughout trial - answering questions and concerns about clinical trial
5.1.1. Interaction between CRCs and participants include; face to face conversations (use of interpersonal skills), oral communication: volume and tone are important, emphasis on important information, interpretation of what is being said.
5.1.2. Non verbal interactions are also critical when interacting with patients. Participants pick up very strongly on body language and facial expressions. proximity to the patient and the overall vibe and aura of the interaction can have a huge effect on the outcome of that conversation.
6. Sponsors
6.1. Interaction of sponsor with CRC include: - negotiating budget - Submission of CRF and additional data - ensuring objectives of clinical trial are being met - report of adverse effects
6.1.1. written
6.1.1.1. Emails, faxes, documentation - making sure all information being shared is clear and consice.
6.1.2. oral
6.1.2.1. telephone conversations, skype- pronunciation is clear and volume and tone is professional
7. Principal Investigator
7.1. Interaction of principle investigator with CRC include: - maintains daily activities for trials - helps to oversee trail with years of experience - ensures CRC understands basis and protocol of trial - any necessary/additional training for safe compliance of clinical trial
7.1.1. oral
7.1.1.1. face to face interactions, telephone calls, skype (speaking and actively listening)
7.1.2. written
7.1.2.1. emails, documentation,
7.1.3. non verbal
7.1.3.1. eye contact, body language, professional tone
8. Regulatory Ethics Board
8.1. Interaction of regulatory ethics board with CRC include: - liaison between REB and sponsor - reports of any adverse effects during clinical trial - IRB application & regulatory submission documents
8.1.1. Written
8.1.1.1. Documentation, emails, should all me eligible and clear to understand
8.1.2. Oral
8.1.2.1. face to face conversations, telephone calls should all include non verbal communication of tone, understanding and interpretation of data, and active listening
9. Biostatistician
9.1. Interaction of biostatistician with CRC include: -exchange of data from clinical trial - submission of data from study site
9.1.1. oral
9.1.1.1. telephone calls, face to face
9.1.1.1.1. proper phone etiquette, clear message with professional volume and tone
9.1.2. written
9.1.2.1. forms, documentation, emails