ALCOA+ Made Practical
Turn the GDP principles into documentation habits you can use the same day.
Audit-Ready Records
Learn how to record, correct, and keep records that hold up to monitoring, audits, and inspections.
Built for Site Practice
For coordinators, investigators, and site teams who want practical clarity before the next monitoring visit.
Build documentation you can defend.
Every clinical trial runs on documentation. What you record matters, and how you record it matters just as much, because together they decide whether your data holds up. This session turns Good Documentation Practices (GDP) into clear actions you can take at the site level. You'll see how everyday choices, the way you write an entry, fix a mistake, or sign off, shape participant safety, compliance, and data integrity. We walk through ALCOA+ the way it shows up in real work, and you'll see weak documentation next to the compliant version, so you can catch a risk before it becomes a finding. This session covers: • What GDP is and why it matters in clinical research • How ALCOA+ applies to both paper and electronic records • Recording data, signatures, and corrections the right way • Common documentation mistakes and how to prevent them • What poor documentation really costs, from regulatory findings to trial risk If you've ever wondered whether your records would hold up to an audit, this gives you a clear answer and a way forward.
ALCOA+ Simple Definitions
Every principle behind a record that holds up, in plain language.
Fix a mistake the right way.
What a clean correction looks like, and why the audit trail matters.
GDP is everyone's job.
Who's responsible for documentation, from the site to the sponsor to the regulator.
Curriculum
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1
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(Included in full purchase)
Good Documentation Practices
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(Included in full purchase)
Document with confidence.
Know your records will hold up to review, audit, and inspection. Build documentation that protects your participants, your data, and your study, aligned with FDA, ICH E6, and ISO 14155.
$12.00