CRC Module
Embarking into the World of Clinical Research
This interactive training platform provides study coordinators, investigators, research assistants, and other site personnel with the information they need to run a successful trial. The content of the Clinical Research Coordinator course is full of up-to-date information curated by research site professionals who are regularly working in the field at various BTC Network site locations.
Being a Coordinator on a Clinical Trial
Daily Duties of a Study Coordinator
Setting Up Source Books
Our Advice
Documents
Differentiate Between Generic Source and Study-Specific Visit Source
Resource Template Downloads
Before Obtaining Consent
Informed Consent
Steps to Consent
Mock Informed Consent Video
Executing the Informed Consent
Documenting the Informed Consent Process
Formatting ICF in the Patient Source Books
Inclusion-Exclusion Criteria
Careful Review of Inclusion/Exclusion Criteria
Vital Signs
Collection Rules
VIDEO: Collecting the Patients BP
Understanding the Readings
Reading a Patient Pulse
Understanding the Reading
Counting Respiration Rates
Understanding the Reading
Blood Oxygen Saturation
Understanding the Reading
Patient Body Temperature
Normal Body Temperature
Physical Measurements
Measurements
Body Mass Index
Helpful Tips
Placement of Leads
VIDEO: Conducting the Patients ECG
Machine Interpretation
Electrocardiogram
PI Should
Obtaining Centrally Read ECGs
Laboratory Room Checklist
Example Laboratory Room
Getting Ready for a Patient Visit
Video Collecting Blood Sample
Clean Catch Urine Sample
Contraception Assessment: What does a Double Barrier Mean?
Urine Pregnancy Test
Urine Drug Screen
Positive or Negative?
Positive or Negative: Answered
Alcohol Breath Test
Video Demonstration Centrifuge/Collecting blood samples
Investigational Medication
DEA 222 Form
Receiving Medication at your Site
Reading the TempTale Device
Reporting a Temperature Excursion
Before Dispensing Study Medication
Dispensing Study Medication
Documenting Dispensing of Medication
Subject Accountability Log
Accountability/ Compliance of Medication
"Scrubbing Charts"
Using ALCOA Guidelines
Proper Corrections per ALCOA Guidelines
Process
Requesting Medical Records
Reviewing Medical Records
Visit Progress Notes
Visit Progress Notes Video
Adverse Events
Serious Adverse Effects
Event Process
Types of Study Visits
Pre-Site Selection Visits (PSSV)
Reviewed During PSSV Visit
Site Initiation Visit (SIV)
Are you ready?
Remote Monitoring Call
Risk Based Monitoring
Routine Site Visits (RMV)
Action Items
Close Out Visits (COV)
Roles During COV
Common Note to File (Templates)
Points of Contact
Note To File Resource Downloads
Course Review