Module 5 Presentations

18/07/2024

Examples of un-blinding

• Slightly different carton colours between Active & Placebo packs.

• Syringes with different pre-printed batch numbers not properly distributed between Active & Placebo packs.

• Different positions of labels or tamper-seals between Active & Placebo when hand-packing.

• Cartons labelled in different orientations between Active and Placebo packs.

• Active & Placebo tablets or pre-packaged supplies not exactly matching each other.

• Label printing consistently different between Active & Placebo print runs; e.g. print density, width of margin.

The Organisation for Professionals in Regulatory Affairs

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Stakeholders

Sponsor • Takes overall responsibility of the trial • Can be an individual, company or institution • Takes responsibility for initiation, management and finance of a clinical trial • Role involves GCP, CTA, GVP, GDP and conduct of the trial • Recruits and selects the investigator

Investigator • A doctor or a person following a profession agreed in EEA • Responsible of the conduct of the clinical trial and medical care of the subjects • Compliance with protocol and informed consent

Ethics Committee • An independent body in EEA, consisting of healthcare professionals and nonmedical members • Responsibility to protect the rights, safety and wellbeing of human subjects • Expresses an opinion on the trial protocol, suitability of the investigators, adequacy of facilities and methods used to obtain informed consent

The Organisation for Professionals in Regulatory Affairs

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