Table 2 Research Documentation Checklist

Project Management: Ensure that research objectives, approach, timeline and budget are planned, communicated and understood.

Yes

No

 1. Project plan (roles and responsibilities, objectives, timeline)

 2. Research review plan

 3. Research publication plan

Personnel Records: Ensure that research records can be traced to competent and appropriate personnel

Yes

No

 1. Job descriptions, resumes or CVs

 2. Signature & initials identification log

 3. Training and ongoing competency (procedures, policies, methods, equipment) records

Critical Equipment Records: Ensure that research records can be traced to well managed and fully operational equipment

Yes

No

 1. Equipment inventory log (unique identification)

 2. Equipment use, maintenance, verification and calibration records

 3. Standard Operating Procedures (SOPs) for use, care and management of equipment

 4. Computer systems used to capture, process, generate and report data should be secure, working as expected and fit for their intended purpose.

Method/Procedure Records: Ensure that research data can be traced to methods or procedures that are well described, working as expected, and fit for their intended purpose

Yes

No

 1. SOPs for routine research methods

 2. Method validation records

 3. On-going quality control records

Standard Operating Procedures: Ensure that procedures are performed consistently, revised as needed and maintained as historical records

Yes

No

 1. Routine procedures: research methods, equipment use, personnel training, data and research management (lab notebooks, research review, reagents and supplies, data (paper and electronic) collection, use and security)

 2. Document management (creation, revision, archiving)

 3. SOP linkages to associated recording forms

Research Records (paper/electronic): Ensure that research data and work (who, what, where, when, how) can be fully reconstructed

Yes

No

 1. Reagent inventory, reagent characterization, verification and preparation records (receipt, verification, storage, expiration and disposition), supply records

 2. Facilities data (temperature, water/air quality, emergency preparedness) if quality critical

 3. Unique identification records for research subjects and samples.

 4. Sample handling and storage procedures

 5. Re-constructable records (accurate, legible, contemporaneous, original, attributable, unchanging, readily retrievable, secure)

 6. Error management procedures (detecting, recording, managing errors, outliers and non-conforming data)