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2 weeks ago
Protocol Review The Investigator holds the ultimate responsibility for the conduct of the study as per the approved protocol. The investigator is responsible for reviewing the protocol, especially the technical aspects.
Technical Discussion Participate in all study related technical discussions to ensure the protocol is scientifically correct and aligned with the research objectives.
Study?Initiation Meeting Attend the study initiation meeting and present the entire study plan/dermatological or clinical assessment plan.
Consent Process Ensure subjects are enrolled in the study only after appropriate, voluntary, informed consent (per ICH GCP guidelines). Answer queries during the ICF process and obtain signatures from subjects.
Dermatological Assessment Perform clinical, visual, and photographic assessments per the approved protocol.
Other Evaluations Conduct medical history, physical examination, and general dermatological examination as required by the protocol.
Lab Result Review Review laboratory test results as required by the protocol.
Safety Assessments Studies conducted under dermatological control fall under the direct purview of a dermatologist to ensure subject safety. If a non clinical evaluator performs assessments, dermatological safety must be evaluated by dermatologists.
Study Plan Work with the Study Manager to prepare the study plan and schedule; participate in planning to ensure successful, seamless study management.
Conduct trials as per ICH GCP and protocol specified guidelines.
Train study staff on study related procedures.
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