Laboratory Data Integrity and Good Documentation Practices

Programme Summary

Strengthen the trustworthiness of laboratory records from first observation to retained result. Participants examine how paper and electronic data can lose context, traceability or integrity, then design practical controls for access, corrections, review and retention. Realistic record scenarios develop disciplined documentation and escalation habits while recognising that software features alone cannot establish reliable laboratory behaviour.

Training Objectives

1 Explain laboratory data lifecycle integrity risks; 2 Strengthen contemporaneous and attributable record practices; 3 Control corrections access and review responsibilities; 4 Identify weaknesses in electronic data handling; 5 Improve investigation and retention of laboratory evidence.

Learning Outcomes

1 Map data flows for a test; 2 Correct a record without obscuring history; 3 Identify integrity risks in laboratory evidence; 4 Prepare a data review checklist; 5 Draft a proportionate integrity improvement plan.

Target Audience

Laboratory Analysts; Laboratory Reviewers; Quality Assurance Officers; Laboratory Supervisors; Laboratory Systems Administrators.

Target Industries

Pharmaceutical Laboratories; Chemical Testing Laboratories; Food Testing Laboratories; Environmental Laboratories; Contract Research Laboratories.

Course Contents

• Module 1 Data Integrity Foundations: Original records metadata and complete context; Attribution legibility and contemporaneous recording; Culture responsibilities and escalation routes.
• Module 2 Laboratory Data Lifecycle: Creation processing review and reporting; Transfers interfaces and manual transcription; Retention retrieval and controlled disposal.
• Module 3 Paper Documentation Controls: Controlled forms and unique identification; Corrections signatures dates and explanations; Attachments calculations and traceable observations.
• Module 4 Electronic Record Controls: Unique accounts and role based access; Audit trails timestamps and original files; Backups recovery and system availability.
• Module 5 Processing and Calculation Controls: Validated calculations and controlled templates; Reprocessing reasons and retained versions; Review of excluded or repeated results.
• Module 6 Data Review and Release: Risk based review of critical records; Completeness consistency and audit trail checks; Authorised approval and unresolved exceptions.
• Module 7 Integrity Deviations: Preserving evidence and limiting further impact; Investigating system and behavioural causes; Corrective actions and effectiveness monitoring.
• Module 8 Documentation Workshop: Reviewing mixed paper and electronic evidence; Correcting records with full traceability; Preparing a targeted data integrity plan.

Assessment

• 40 single best answer questions, including applied scenarios; one mark per question.
• 60 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Supplied reference pack and calculator permitted; external internet and AI prohibited.
• Individual applied assessment (30 minutes): Review a fictional laboratory record set, identify integrity weaknesses and produce corrected examples with a proportionate review and control plan.
• Assessment criteria: Accurate identification of integrity risks; Traceable correction and review practices; Feasible controls protecting original evidence.
• Pass each component separately: 30/40 written marks (75%) and at least 70% on the applied task.
• All mandatory criteria must pass: Retain original data and change history.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records laboratory documentation and data integrity skills; it does not validate a computerised system or replace authorised record review.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

222

Total teaching hoursTotal teaching hoursTotal teaching hours

12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.12 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 20 delegates.Maximum 20 delegates.Maximum 20 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

Experience creating, reviewing or managing laboratory records is recommended. No specialist information technology qualification is required.Experience creating, reviewing or managing laboratory records is recommended. No specialist information technology qualification is required.Experience creating, reviewing or managing laboratory records is recommended. No specialist information technology qualification is required.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Review a fictional laboratory worksheet for 20 minutes and identify unclear entries, missing context and uncontrolled changes.Review a fictional laboratory worksheet for 20 minutes and identify unclear entries, missing context and uncontrolled changes.Review a fictional laboratory worksheet for 20 minutes and identify unclear entries, missing context and uncontrolled changes.

End of course assessmentEnd of course assessmentEnd of course assessment

40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).40 question written exam (60 minutes) and individual applied task (30 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.75% written and 70% applied, passed separately; full attendance. All mandatory criteria must pass.