Data Collection and Source Documentation Training | CRC Course
Data Collection and Source Documentation
Data integrity is the reason clinical trials exist. If the data are unreliable, the entire enterprise -- the science, the regulatory submission, the years of participant sacrifice -- produces nothing of value. The CRC is the first link in the data integrity chain: the person who creates source documents, transcribes data into case report forms, and responds to queries when discrepancies are found. This course teaches the principles, systems, and daily practices that produce data worthy of the trust we place in it.
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
~12
about
h
Final exam50 questions · 80% to pass · 90 minutes · up to 3 attemptsICH E6(R3)Intermediate
What you will be able to do
01Apply the ICH E6(R3) data integrity criteria -- attributable, legible, contemporaneous, original, accurate, complete, secure, and reliable -- to all source documentation and data collection activities, while recognizing the industry mnemonic ALCOA-CCEA (which adds Consistent, Enduring, and Available) as a complementary but distinct framework
02Create source documents that withstand source data verification and regulatory inspection
03Execute accurate data transcription from source documents to case report forms, whether paper or electronic
04Navigate electronic data capture (EDC) systems with proficiency, including data entry, edit checks, and query resolution
05Manage data queries efficiently and accurately, maintaining query resolution timelines
06Implement data governance practices consistent with ICH E6(R3) Annex 1, Section 4 (Data Governance)
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
IData integrity principles for the CRC4 lessons · knowledge check
1.1Data integrity per ICH E6(R3): the eight criteria that govern every data point you create
1.2ICH E6(R3) data governance: what changed and why it matters (Annex 1, Section 4)
1.3The consequences of data integrity failures: real cases, real outcomes
Transcription discipline: source to CRF without error
Apply the read-transcribe-verify method, identify high-risk data elements, navigate transcription challenges, and execute CRF correction procedures for paper and electronic systems.
Each point links back to its section of the guideline.
Narrated end to end
Listen when you can’t sit down to read.
Saves your place
Pick up exactly where you stopped.
Studied as part ofthe CRC track.
Data Collection and Source Documentation is the sixth 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. Data Collection and Source Documentation is the sixth 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: “Designing and using source document worksheets” and “Transcription discipline: source to CRF without error”.
Is it aligned to ICH E6(R3)?
Yes. The course works from ICH E6(R3).
Does course access expire?
No. Access is yours for good. The CRC credential the track awards is valid for two years.
Study Data Collection and Source Documentation,within the CRC track.
One enrollment opens all eight courses, every final exam and the certificate. Course access does not expire.
Not separately. Data Collection and Source Documentation is the sixth 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: “Designing and using source document worksheets” and “Transcription discipline: source to CRF without error”.
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
Designing and using source document worksheets
Apply worksheet design principles to create SDV-ready source documentation, incorporate quality prompts, evaluate worksheets against protocol requirements, and manage version control.
Transcription discipline: source to CRF without error
Apply the read-transcribe-verify method, identify high-risk data elements, navigate transcription challenges, and execute CRF correction procedures for paper and electronic systems.