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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:
Online, asynchronous, self-paced 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.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 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 access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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