RECORDREFERENCE OUTLINE

GLP Study Director Appointment Record

Appointment record establishing the single point of study control good laboratory practice is built around: a named individual dated before study start, qualification evidenced against this study type, authority stated in exercisable terms including the authority to stop the study, the quality-assurance interface, and a replacement procedure documented before it is needed. Maps to 21 CFR Part 58 and the OECD GLP Principles.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
21 CFR Part 58OECD GLP Principles
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

Good laboratory practice organises a study around one named individual carrying overall responsibility for its conduct and its final report. That single point of control is the structural feature separating it from every other laboratory quality system. The characteristic failure is a hollow appointment: responsibility conferred without the authority to amend the plan or stop the study, which only becomes visible when something goes wrong.

What's Inside

✓Appointment of a named individual, dated before study start rather than back-filled at report time
✓Qualification for this study type with evidence references, not a generic curriculum vitae attached
✓Authority conferred, listed in exercisable terms including the authority to stop the study
✓Interface with the quality assurance unit, including how its findings reach the director directly
✓Named deputy and a replacement procedure written before anyone actually needs to use it
✓Dated handover record for a mid-study change, leaving no period without a point of control
✓Acceptance signature and the commitment to sign the final report compliance statement later

How to Use It

1Name an individual, never a job title or a team; the appointment is what makes the study attributable to a person.
2Date the appointment before the study starts; one documented afterwards leaves the opening period with no point of control.
3Check each authority line is actually true on the day of appointment, not aspirational for later in the study.
4Evidence qualification against this study type; experience in a different model is not qualification for this one.
5Write the replacement procedure before you need it — a mid-study handover with no dated transfer leaves a period nobody owns.
6Confirm the director accepts the commitment to sign the compliance statement before the study begins generating data.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Appointment
2Qualification for This Study
3Authority Conferred
4Interface with the Quality Assurance Unit
5Replacement Procedure
6Acceptance and Compliance Statement Commitment
REGULATORY CONTEXT

21 CFR Part 58 and the OECD Principles of Good Laboratory Practice both make the study director the single point of study control, responsible for the conduct of the study and for the final report and its compliance statement, and both require a replacement to be documented. Neither specifies who is qualified for your study type, what authority your organisation grants, or how a handover is evidenced — those remain yours to define. The appointment-record structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 58OECD GLP Principles
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