Good Documentation Practices – General Rules of Data Integrity

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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