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Research Ethics Board William Osier Health System 2100 Covered Drive East Brampton, ON L6R 3J7 Phone: (905) 4942120 ext.50448 Fax: (905) 4946562PLANNED PROTOCOL DEVIATION FORM The WOES Research Ethics
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How to fill out planned deviation format
How to fill out planned protocol deviation form
01
Start by clearly identifying the planned protocol deviation and the reason for it.
02
Provide a detailed description of the deviation, including the date and time it occurred.
03
Mention the specific section or requirement of the protocol that is being deviated from.
04
Include any supporting documents or evidence that can justify the deviation.
05
Clearly state the potential impact of the deviation on the study and participant safety.
06
List any corrective actions or preventative measures that will be taken to minimize future deviations.
07
Obtain appropriate signatures and approvals from the relevant stakeholders.
08
Submit the completed form to the designated authority for review and record keeping.
Who needs planned protocol deviation form?
01
Planned protocol deviation forms are typically required by researchers, clinical investigators, study coordinators, and other personnel involved in conducting clinical trials or research studies that follow a predefined protocol.
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What is planned protocol deviation form?
Planned protocol deviation form is a document that is used to report any anticipated deviations from the study protocol.
Who is required to file planned protocol deviation form?
The principal investigator or study coordinator is usually required to file the planned protocol deviation form.
How to fill out planned protocol deviation form?
The planned protocol deviation form can typically be filled out by providing details of the deviation, the reason for it, and any impact it may have on the study.
What is the purpose of planned protocol deviation form?
The purpose of the planned protocol deviation form is to document and justify any planned deviations from the study protocol in order to maintain integrity and transparency.
What information must be reported on planned protocol deviation form?
The planned protocol deviation form must include details of the deviation, the reason for it, any impact on the study, and any corrective actions taken.
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