Protocol deviations : the importance of communication and documentation /
The present case study depicts a deviation initiated by an investigator, who believes that after spontaneously altering an inclusion criterion, the study's enrollment could improve, while not putting participants at increased risk. Federal regulations, institutional policies, and international...
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| Format: | eBook |
| Language: | English |
| Published: |
London :
SAGE Publications Ltd,
2020.
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| Series: | SAGE Research Methods Cases: Medicine and Health.
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| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
| Summary: | The present case study depicts a deviation initiated by an investigator, who believes that after spontaneously altering an inclusion criterion, the study's enrollment could improve, while not putting participants at increased risk. Federal regulations, institutional policies, and international guidelines oblige investigators to follow precisely the research procedures described in a clinical trial, having been approved by an institutional review board (IRB). However, there are occurrences (often detected during post-approval monitoring) where a study procedure is not adhered to, precipitating what is commonly known as the eponymous protocol deviation. At times, an investigator will initiate a change to the protocol, a "planned deviation," that may be seen as necessary, but that simultaneously is not considered to put the research participants at increased risk. Exacerbating this action are the lack of communication with a study's sponsor and notification to and approval from the IRB. To understand the importance of adhering to the protocol and regulatory requirements, becoming familiar with the types of deviations, along with interacting with study sponsors and the IRB, and consistently documenting all details of protocol deviations are a crucial practice. Avoiding or reconciling protocol deviations is necessary to maximize the scientific and ethical soundness of human subjects research, while safeguarding the safety, rights, and well-being of study participants. |
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| Physical Description: | 1 online resource. |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 9781529726664 1529726662 |