Trusted Resource for Clinical Trials, Protocols & Progress
Traditional consent forms often fail to communicate effectively with patients due to language complexity, format, and static presentation. Multimedia tools can:
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Protocol amendments can impact participants in several ways. These may include changes in:
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Electronic informed consent (eConsent) refers to using digital technology to present information about a clinical trial, confirm understanding, and capture a participant’s consent electronically. It may involve:
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Accurate and complete documentation proves that informed consent was obtained ethically and legally. Inadequate records can lead to inspection findings, data exclusion, and even study termination.
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Children and older adults may face limitations in their ability to fully understand study procedures, risks, and rights. Regulatory agencies mandate that these populations receive enhanced protections during the consent process.
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As per ICH-GCP E6(R2), participants must be informed that they:
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Incomplete or non-compliant EC submissions lead to delays, queries, or outright rejections. A thorough package ensures:
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An IRB is an independent committee formally designated to review and monitor research involving human subjects. According to USFDA regulations (21 CFR Part 56) and ICH-GCP E6(R2), no clinical trial involving humans can begin without IRB approval.
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A conditional approval is granted when an EC/IRB has reviewed the submission package and finds it generally acceptable, but requires certain changes, clarifications, or additional documents before full approval is issued.
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Delays in EC reviews can postpone:
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