Good Documentation Practices – General Rules of Data Integrity

Description:

This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special record-keeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDocPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

Curriculum for this course:
Introduction
Overview 50 secs
Learning objectives 25 secs
Who should take this course? 1 min 04 secs
Course modules 1 min 30 secs
Module 1: The Starting Line
Overview 1 min 09 secs
What are Good Documentation Practices (GDocP)? 1 min 25 secs
Examples 1 min 14 secs
Entire document life cycle 1 min 49 secs
Create a SOP 1 min 33 secs
Benefits of GDocP 1 min 41 secs
Module 2: General Rules
Overview 1 min 01 secs
Document Types 54 secs
Fundamentals of Good Documentation Practices – Part 1 1 min 50 secs
Fundamentals of Good Documentation Practices – Part 2 1 min 45 secs
Signatures 45 secs
Document control 1 min 39 secs
Minimum number of approvers 1 min 20 secs
Never back date! 56 secs
Specimen file 1 min 01 secs
Electronic systems 1 min 40 secs
Date and time format 1 min 30 secs
Good practice 1 min 30 secs
Be consistent 2 min 30 secs
Format 1 min 40 secs
Languages – Correct grammar 1 min 30 secs
Use indelible ink 1 min 23 secs
Do not 52 secs
Blue of black 1 min 21 secs
Scrap paper and post-its 2 min 30 secs
Transcribing 1 min 10 secs
Late Entries 1 min 02 secs
Blank fields 1 min 23 secs
Annotations 1 min 52 secs
Additional pages 1 min 05 secs
Instrument print-outs 1 min 12 secs
Ditto 1 min 17 secs
Conclusion
Final Assessment
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