Clinical Trials: SOP for GCP

SOP for Informed Consent Process in Clinical Trials

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The purpose of this SOP is to establish a standardized informed consent process for clinical trials, ensuring that participants or their legally authorized representatives are adequately informed about the nature of the trial, potential risks, benefits, and their rights. This process ensures compliance with ICH-GCP, WHO, FDA, EMA, and CDSCO guidelines and safeguards the autonomy and welfare of trial participants.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Re-consent Procedures

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The purpose of this SOP is to describe the standardized process for re-consenting clinical trial participants whenever new information, safety updates, or protocol amendments arise that may affect their willingness to continue participation. This ensures protection of participants’ rights, safety, and autonomy, in compliance with ICH GCP, FDA, EMA, CDSCO, and WHO guidelines.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Vulnerable Populations and Witness Consent

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The purpose of this SOP is to define standardized procedures for obtaining informed consent from vulnerable populations, including illiterate participants, children, cognitively impaired individuals, and others requiring additional protection. It also specifies the role of impartial witnesses during the consent process. This ensures compliance with ethical principles and regulatory requirements while safeguarding participant rights.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Audio-Visual Recording of Consent (Where Required by Law/Protocol)

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The purpose of this SOP is to describe the procedure for conducting and documenting audio-visual (AV) recordings of the informed consent process for clinical trial participants, where mandated by law, regulatory authority, or trial protocol. AV recording enhances transparency, ensures participant comprehension, and provides verifiable documentation for regulatory inspections.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Pediatric Assent and Parental Consent

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The purpose of this SOP is to define the process for obtaining pediatric assent and parental/legal guardian consent for the participation of children in clinical trials. This ensures the rights, safety, and well-being of minors are protected and that participation is ethically and legally sound, in compliance with international and national regulations.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Data Privacy Rights in Consent and Withdrawals

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The purpose of this SOP is to define procedures for ensuring participant data privacy rights during the informed consent process and in the event of consent withdrawal. This includes compliance with international data protection laws such as GDPR (EU), HIPAA (USA), ICH-GCP, as well as national regulations (e.g., CDSCO in India, EMA in Europe, and FDA in the USA).

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Global SOPs (Applicable to all Agencies), SOP for GCP