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GDocP: Good Documentation Practices and Data Integrity

GDocP: Good Documentation Practices and Data Integrity Certification Training

 
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Program/Course ID:ELM-104
Enrollment Period:12 months.
Average Learning Time:~60 minutes.
Additional Resources:Supplemental materials & activities.
Accredited Program:0.1 CPD Credits.
Method of Training:
Self-paced, online, asynchronous eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote or invoice.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with QR validation code.

Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.

It may have been updated or discontinued.
Check for newer version in our catalog.


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Outline:


Introduction
Overview
Learning objectives
Who should take this course?
Course modules

The Starting Line
Overview
What are Good Documentation Practices (GDocP)?
Examples
Entire document life cycle
Create a SOP
Benefits of GDocP

General Rules
Overview
Document Types
Fundamentals of Good Documentation Practices - Part 1
Fundamentals of Good Documentation Practices - Part 2
Signatures
Document control
Minimum number of approvers
Never back date!
Specimen file
Electronic systems
Date and time format
Good practice
Be consistent
Format
Languages - Correct grammar
Use indelible ink
Do not
Blue of black
Scrap paper and post-its
Transcribing
Late Entries
Blank fields
Annotations
Additional pages
Instrument print-outs
Ditto

Corrections
Overview
Making corrections
Draw a Line
Explanation codes
Correction tape & fluid
Explanations for the correction
Verification
Multiple corrections
Avoid asterisks
Review activity

Logbooks
Overview
Elements of a Logbook
Supporting Procedures
Keep On-Site
Data entering ground rules
Reviewing recorded data
Examples
Retrieving logbooks
Logbook auditing
Signature blocks
Page numbering
Avoid gaps
Attachments and print-outs

General Test Results
Overview
Protocol Generation
Protocol Execution Tips
Variable Data
Errors Can Be Costly
Expected Results
Calculations & Formula
Oops & Uh-Ohs
Accountability
Rules of Thumb
Units of Measurement
Attachment -Reminder
Legal Factors
Review activity

Conclusion


Final assessment


Certification

Objectives:


Skill Level:
Basic

This training program has been developed to train employees with Basic Knowledge of Good Documentation Practices (GDocP).

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Benefits of Training with Biopharma Institute

Immediate Course Access: Login details, instructions, and payment confirmation are emailed immediately upon online enrollment.
Self-Paced eLearning: Enjoy 24/7 access to all course materials and assessments for 12 months.
Open Enrollment: No prerequisites or prior work experience required to start.
Expert-Developed Content: Courses are designed by subject matter experts (SMEs) in their respective fields.
Up-to-Date & Validated: Training is regularly updated to meet current regulations and is third-party validated or accredited.
Optimized for Learning: Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention.
Secure Access: Encrypted connections, firewalls, and daily malware scans ensure security and system performance.
Flexible Assessments: Multiple-choice exams can be retaken until a passing score is achieved.
Instant Certificates: Certificates are issued instantly in secure PDF format with watermark, unique validation code, and QR code for verification.
Training Verification: Certificates can be verified online using a QR code or unique ID. Digital badges are included with professional certifications.
Manager Access: A secure portal allows managers to view and download enrollment reports, training records, account balances, and more.
SCORM-Compliant: Courses can be integrated directly into most corporate Learning Management Systems (LMS).
Purchase Orders: We accept POs from all companies. Request an invoice to start the procurement process.
Employer Reimbursement: Some employers may cover training costs -check your company's reimbursement policy.
Financial Assistance: Payment plans are available for eligible learners, or purchase courses individually as needed.
Career Advancement: Professional certifications highlight dedication to career growth, enhance resumes, provide interview talking points, and equip learners with practical job skills.

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