Study Start-Up and Site Activation Training | CRC Course
Study Start-Up and Site Activation
Study start-up is where trials are won or lost at the site level. This course covers the entire arc from feasibility assessment through first patient enrolled — budget and contract negotiation, regulatory submissions, essential record collection, and the site initiation visit. Every lesson addresses what you will actually do and the timelines you will actually face.
Studied within the Clinical Research Coordinator track. One payment of $249 USD covers all eight courses and the certificate.
Modules
7
Lessons
28
Knowledge checks
7
Study time
~about 11h
Final exam50 questions · 80% to pass · 90 minutes · up to 3 attemptsICH E6(R3)
What you will be able to do
01Conduct a comprehensive protocol feasibility assessment that honestly evaluates site capabilities, patient population, and resource requirements
02Navigate the budget negotiation and contract execution process, including fair market value considerations and common negotiation pitfalls
03Prepare and submit complete IRB/IEC applications with all required supporting documentation
04Manage the essential record collection process from investigator CVs through laboratory certifications
05Execute CRC responsibilities during the site initiation visit and implement post-SIV action items within required timelines
06Apply regulatory submission requirements for FDA (1572), central IRB, and local IRB processes
Seven modules,one final exam.
Seven modules and twenty-eight lessons, each module closing with a knowledge check, and a final exam to complete the course.
A knowledge check closes every module
FreeTwo lessons are open to read now
Pass the final exam at 80% to complete the course
IProtocol receipt and initial review4 lessons · knowledge check
1.1Receiving a new protocol: what to look for in the first 48 hours
1.2
Read two lessonsbefore you enroll.
Both are open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Module II · Lesson 225 min
Resource and infrastructure evaluation: staff, space, equipment, and time
Assess site infrastructure requirements including staff availability, equipment needs, storage capacity, and aggregate time burden to determine whether your site can conduct the study properly and safely.
Fair market value and anti-kickback considerations
Understand fair market value principles, the federal Anti-Kickback Statute, and institutional compliance processes that govern clinical trial payments.
Each point links back to its section of the guideline.
Narrated end to end
Studied as part ofthe CRC track.
Study Start-Up and Site Activation is the second of eight courses in the Clinical Research Coordinator track. It is not sold on its own: one enrollment opens every course, every final exam and the certificate.
Clinical Research Coordinator
Specialized training for clinical trial coordination and site operations
Courses
8
Lessons
226
Study time
~100 h
Score 80% or higher on every final exam and your credential is issued, with the printable certificate included.
$249 USDOne payment for the whole track. Access does not expire.
How it is enrolled in, what the exam asks, and what you can read first.
Can I take this course on its own?
Not separately. Study Start-Up and Site Activation is the second course in the Clinical Research Coordinator track, and the track is enrolled in as one: all eight courses, every final exam and the certificate, for one payment of $249 USD.
What does the final exam ask?
Fifty questions in 90 minutes, with 80% needed to pass, and up to three attempts. Each module also closes with a knowledge check.
Can I read any of it before I enroll?
Yes. Two lessons are open now: “Resource and infrastructure evaluation: staff, space, equipment, and time” and “Fair market value and anti-kickback considerations”.
Is it aligned to ICH E6(R3)?
Yes. The course works from ICH E6(R3).
Does course access expire?
Study Study Start-Up and Site Activation,within the CRC track.
One enrollment opens all eight courses, every final exam and the certificate. Course access does not expire.
No. Access is yours for good. The CRC credential the track awards is valid for two years.
$29 USD
of $249 USD
Can I take this course on its own?
Not separately. Study Start-Up and Site Activation is the second course in the Clinical Research Coordinator track, and the track is enrolled in as one: all eight courses, every final exam and the certificate, for one payment of $249 USD.
Can I read any of it before I enroll?
Yes. Two lessons are open now: “Resource and infrastructure evaluation: staff, space, equipment, and time” and “Fair market value and anti-kickback considerations”.
Read two lessonsbefore you enroll.
Both are open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Module II · Lesson 225 min
Resource and infrastructure evaluation: staff, space, equipment, and time
Assess site infrastructure requirements including staff availability, equipment needs, storage capacity, and aggregate time burden to determine whether your site can conduct the study properly and safely.
Fair market value and anti-kickback considerations
Understand fair market value principles, the federal Anti-Kickback Statute, and institutional compliance processes that govern clinical trial payments.