Global

Good clinical practice for clinical research staff

A ready-made course you customise for your organisation, with a live session deck and two surveys. You only add the 15 details that are specific to your organisation.

See the live deckSee the full outline
Try the coursePreview the survey
Length
50 min
Lessons
6 lessons
Frequency
Before starting trial work
Last reviewed
21 Oct 2026
ICH-GCP principles
What would you do?

A busy clinic. The research nurse, Sam (fictional

In the course you choose a path, see what happens and get feedback. This is one of 34 interactive activities.

What's included

Three pieces that work together

Copy once, get everything. Learners prepare on their own, you answer questions live, and the surveys tell you what stuck.

Self-paced course

Short lessons with real workplace scenarios, not walls of text.

  • 6 lessons, about 50 minutes
  • Scenario, sorting activity, accordion, flashcards and quizzes

Live session deck

An AhaSlides presentation to run after the course, in person or online.

  • 10 slides
  • Poll, open-ended slides
  • A closing slide for your contacts

Two surveys

Find out what landed, and whether people use it on the job.

  • Post-course feedback, about 2 minutes
  • 30-day check-in
  • Anonymous by default
  • Results feed your next refresher

Learning objectives

At the end of this course, learners can

Each objective and the lesson that covers it.

IDObjectiveSourceWhere it's covered
TO 150.0Achieve ≥ 80% on the final assessment-Whole course
LO 150.1.1Explain the purpose of GCP and apply the principle that participants' rights, safety and well-being come firstICH E6(R3) PrinciplesLesson 1: ICH-GCP principles
LO 150.2.1Take part in the informed consent process correctly, including re-consent and impartial witnessesICH E6(R3) 2.8; Declaration of HelsinkiLesson 2: Consent in research
LO 150.3.1Report adverse events and serious adverse events to the sponsor within the protocol's timelines + your infoICH E6(R3) 2.7.2; EU CTR Art 41Lesson 3: Safety reporting in trials
LO 150.4.1Keep source records that are attributable, legible, contemporaneous, original, accurate and completeICH E6(R3) 2.12Lesson 4: Data integrity and source documents
LO 150.5.1Record protocol deviations and prepare for monitoring, audits and inspections + your infoICH E6(R3) 2.5, 3.9.3; EU CTR Art 52Lesson 5: Deviations and audits

Your part: what a template can't do for you

  • Your workplace details: fill in the 15 highlighted fields so the course describes your own policies, contacts and locations.
  • Records: record completion in your own LMS or record system.

Course outline

6 lessons, about 50 minutes

Minutes per lesson are an estimate, shared out by page count.

ContentInteractiveVideoYou customise
1

ICH-GCP principles

4 pages

10 min
Before you beginNoteYour infoList
What GCP is forTextKey factAccordionYour infoQuiz
The 11 principlesFlashcardsQuiz
DelegationTextYour infoScenario
2

Consent in research

3 pages

8 min
Free and informedTextProcessYour infoQuiz
When someone can't consent aloneTextYour infoSorting activity
New information and re-consentTextScenarioQuiz
3

Safety reporting in trials

3 pages

8 min
AE or SAE?TextAccordionMulti-select quiz
Report SAEs immediatelyTextTimelineYour infoNote
What the sponsor does nextTextQuiz
4

Data integrity and source documents

3 pages

8 min
Source recordsTextFlashcardsQuiz
Correcting a recordTextSorting activity
Confidentiality and keeping recordsTextYour infoScenarioQuiz
5

Deviations and audits

3 pages

8 min
Protocol deviationsTextSorting activityNoteYour infoQuiz
Immediate hazards and serious breachesTextScenario
Monitoring, audits and inspectionsTabsTextYour infoQuiz
6

Final assessment

3 pages

8 min
Final assessment (part 1)TextQuizKnowledgeCheck orderingMulti-select quiz
Final assessment (part 2)Matching quizQuizMulti-select quiz
CompletionKey factListNoteYour infoButtonYour info

Live deck and surveys

10 slides to run live, two surveys to close the loop

Pink slides are interactive. Both surveys are anonymous; pink questions are written for this course.

TitleTitle + agenda - "GCP in practice" (notes: template disclaimer; all cases fictional; not a certificate on its own)
PollWhich part of GCP do you find hardest day to day?" - Consent · Safety reporting · Source records · Deviations · Audit readiness
Pick answerWhat comes first if it conflicts with science?" - Recruitment · Participants' rights, safety and well-being ✔ · Budget · Timelines [MED-20-V04]
ContentThe 11 ICH E6(R3) principles on one slide [MED-20-V03]
Scenario pollA participant can't read the form. What now?" - Family member signs · Impartial witness for the whole discussion ✔ · Exclude them · Investigator signs [MED-20-V11]
Correct orderSAE aware → Tell investigator → Report to sponsor (EU ≤ 24 h) → Follow-up [MED-20-V16]
CategoriseImportant deviation / Minor deviation - ineligible participant enrolled · visit one day outside window · old consent version signed [MED-20-V26]
ContentALCOA - correcting a record the right way [MED-20-V19]
Open-endedWhat would an inspector find in our files today?
ClosingClosing - {{SURVEY_URL}}, {{COURSE_URL}}, {{EDUCATOR_CONTACT}}
Post-course feedback: 11 questions, about 2 min
  1. Overall rating 5 stars
  2. Relevant, realistic, right length, helpful activities agree/disagree grid
  3. What was most useful? multi-select
  4. Confidence before this course, and now 1-5 scale
  5. How ready do you feel to take consent for a trial on your own (if delegated)? 1-5 scale
  6. Which area do you want more support on? multiple choice
  7. Do you know where your trial's deviation log is kept? multiple choice
  8. On my team, I can report a mistake or deviation without fear of blame. 1-5 scale
  9. One thing we should change or add open text
  10. Would you recommend this course? NPS
30-day check-in
  1. Have you used what you learned since the course? multiple choice
  2. How confident are you today? Compare with day 1 1-5 scale
  3. Do you know where to find the protocol, the delegation log and the site's SOPs? yes / no / not sure
  4. A moment where the training helped, or where you weren't sure open text
  5. Which topics should the next refresher focus on? ranking

Results show whether people use the training on the job, not just whether they finished it.

Make it yours

15 fields to fill in, and you're ready

Everything else is done. These are the details only your organisation knows; each one is highlighted inside the course.

  • Whether your organisation or sponsors recognise this course{{GCP_CERTIFICATE_RECOGNITION}}
  • Gcp refresher interval{{GCP_REFRESHER_INTERVAL}}
  • National trial regulations{{NATIONAL_TRIAL_REGULATIONS}}
  • Local consent law{{LOCAL_CONSENT_LAW}}
  • Delegation log location{{DELEGATION_LOG_LOCATION}}
  • Consent filing procedure{{CONSENT_FILING_PROCEDURE}}
Show all 15 fields
  • Form, system and sponsor contact{{SAE_REPORTING_ROUTE}}
  • Record retention policy{{RECORD_RETENTION_POLICY}}
  • Deviation log and criteria{{DEVIATION_LOG_AND_CRITERIA}}
  • Audit readiness checklist{{AUDIT_READINESS_CHECKLIST}}
  • LMS or record system{{LMS_OR_RECORD_SYSTEM}}
  • Survey URL{{SURVEY_URL}}
  • Live session URL{{LIVE_SESSION_URL}}
  • Course URL{{COURSE_URL}}
  • Educator contact{{EDUCATOR_CONTACT}}

FAQ

Common questions

Can I run good clinical practice for clinical research staff training online?

Yes. The course is self-paced and online, and the live deck lets you add a live session in the room or online.

How often is this training needed?

Before starting trial work, then a refresher set by the sponsor or institution (your gcp refresher interval); ICH E6(R3) requires staff to be qualified by training for their tasks but sets no interval. US NIH-funded trials are reported to expect a refresher every three years (unverified).

Who needs this training?

Research nurses, clinical research coordinators, study-site staff, investigators new to research, and CRO and sponsor staff (monitors, project assistants).

What records should I keep?

Record completion in your own LMS or record system, so you can show who finished the course and when.

Can I edit the content?

Yes, everything. Change the wording, swap scenarios for ones from your workplace, add your logo, or remove parts that don't apply.

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Ready to run it?

Open the live deck to see how the session runs alongside the course and both surveys.

See the live deck