Study-specific procedures and plans to facilitate the management of the research and can also be used in the event of an audit to justify the approaches taken.
Topics:
Adverse Events | Monitoring | Consent | Tools to help you conduct your research
Adverse Events
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Investigators in the Harvard Medical Practice Study define an 'adverse event' as "an injury that was caused by medical management (rather than the underlying disease) and that prolonged the hospitalization, produced a disability at the time of discharge, or both." Serious Adverse Event (SAE) is defined as: An untoward occurrence that results in death; is life-threatening; requires hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; or consists of a congenital anomaly or birth defect. There are slight differences in definition for IMPs and non IMPs; Clinical Trial Regulations should be referred to for IMPs. Downloads: |
Monitoring
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The type of monitoring may differ greatly between studies. A plan will help establish the overall framework for the oversight and monitoring of a study. When formulating a plan the study team should consider the protocol, phase, intervention(s), target population, subject safety and privacy, risks and benefits involved in the study, data integrity and confidentiality, study coordination, and how the team will address each of these elements. Downloads:
Modular courses (TGHN e-Learning): |
Consent
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The Participant Information Sheet and Consent Form are key documents and a major consideration during ethical review. Downloads: |
Tools to help you conduct your research
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Study-specific procedures and plans to facilitate the management of the research and can also be used in the event of an audit to justify the approaches taken. Downloads:
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