Anchor Medical Research LLC Safety Reporting Policy‍

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Effective Date: 12/5/2024

Last Updated: 12/5/2024

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Anchor Medical Research LLC ("we," "us," or "our") is committed to ensuring the safety and well-being of all participants in our clinical trials. This Safety Reporting Policy outlines our procedures for identifying, reporting, and managing safety issues, including adverse events (AEs) and serious adverse events (SAEs), that occur during the course of clinical research. We adhere to the highest standards of clinical practice to ensure participant protection and compliance with relevant regulations, including those set forth by the FDA, ICH-GCP, HIPAA, and other applicable regulatory bodies.

1. Reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)

1.1 Adverse Events (AEs)

An Adverse Event (AE) is any undesirable experience associated with the use of a study intervention or the study protocol, regardless of whether it is considered related to the study. AEs may include symptoms, side effects, or other health issues that occur during the clinical trial.

1.2 Serious Adverse Events (SAEs)

A Serious Adverse Event (SAE) is any adverse event that:

  • Results in death,
  • Is life-threatening,
  • Requires hospitalization or prolongation of existing hospitalization,
  • Results in persistent or significant disability or incapacity,
  • Is a congenital anomaly or birth defect,
  • Or is otherwise deemed medically significant by the investigator.

1.3 Reporting Responsibilities of Study Participants

  • Participant Reporting: All participants are encouraged to report any adverse events or health concerns, whether or not they are related to the study. If you experience any symptoms, side effects, or other health issues, it is crucial to report them to the study team immediately.
  • Immediate Reporting: Adverse events, particularly serious ones, must be reported as soon as they are identified. Participants should provide detailed information about the event, including the onset time, severity, and any medical treatment required.

1.4 Reporting Responsibilities of Study Team

  • Investigator Reporting: Study investigators are responsible for ensuring that all AEs and SAEs are promptly and accurately reported to the Anchor Medical Research LLC Safety Officer, ethics committees (IRBs), and appropriate regulatory authorities in compliance with all applicable laws and regulations.
  • Monitoring and Documentation: The study team must monitor and document all adverse events throughout the course of the trial. This includes maintaining accurate records of any safety reports and ensuring timely submission of safety data.

2. Safety Reporting Procedures

2.1 Immediate Action

When an adverse event or serious adverse event is reported, the following steps should be taken immediately:

  • Initial Assessment: The study team must assess the severity of the event and its potential relationship to the study intervention. Medical professionals should determine if immediate treatment or further medical care is needed.
  • Participant Care: If the AE or SAE poses a threat to participant safety, appropriate medical interventions must be provided. Participants should be monitored until the adverse event resolves or the risk is mitigated.

2.2 Documentation and Reporting

All reported AEs and SAEs must be documented thoroughly. The documentation should include:

  • A description of the event,
  • The severity of the event,
  • A timeline of the event’s onset and resolution,
  • Any relevant medical treatment or intervention,
  • Any corrective actions taken.

The following reports must be submitted:

  • Internal Reporting: The event must be reported to Anchor Medical Research LLC’s Safety Officer immediately, and all related details should be documented in the study records.
  • Regulatory Reporting: Any SAE must be reported to the relevant regulatory authorities (e.g., FDA, EMA) within the required time frame (usually within 24 to 72 hours, depending on the severity).
  • IRB/IEC Reporting: The event should be reported to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), especially if the event significantly impacts participant safety or the study protocol.

2.3 Safety Data Evaluation

  • Regular Review: All AEs and SAEs are evaluated regularly by the study team and the Safety Officer to identify trends, assess the risk of continuing the study, and determine if the trial protocol needs to be amended to ensure participant safety.
  • Risk Mitigation: If a particular risk emerges as significant, additional safety measures may be implemented, such as additional monitoring or modifying the study protocol.

3. Participant Safety and Follow-Up

3.1 Participant Safety Monitoring

  • Continuous Monitoring: Throughout the clinical trial, participants’ safety is continuously monitored. Any report of an adverse event is reviewed by the medical staff, and appropriate measures are taken to ensure their health and well-being.
  • Follow-Up: Participants who report adverse events will be monitored closely for the duration of the event to ensure that their health is not jeopardized. Additional follow-up appointments may be scheduled to assess recovery or manage ongoing issues.

3.2 Informing Participants

  • Safety Updates: Participants will be informed of any relevant safety issues that arise during the study. This may include new risks, changes to study protocols, or updates on treatment procedures.
  • Informed Consent: In the case of significant changes to the safety protocols or study design, participants will be asked to provide updated informed consent.

4. Compliance with Regulatory and Ethical Standards

4.1 Regulatory Compliance

Anchor Medical Research LLC adheres to all local, state, and international regulatory requirements for the reporting of adverse events, including:

  • FDA regulations,
  • Good Clinical Practice (GCP) guidelines,
  • ICH E6 guidelines,
  • HIPAA for the protection of participant health information,
  • EU pharmacovigilance requirements under GDPR for participants in Europe.

4.2 Ethical Standards

All safety reports are handled in accordance with our ethical guidelines, including the Ethical Standards Policy and the Participants' Rights and Responsibilities Policy, to ensure transparency, participant protection, and unbiased decision-making in all clinical trial activities.

5. Consequences of Non-Compliance

Failure to report AEs and SAEs in a timely and accurate manner may result in serious consequences for both the study and the individuals involved. This may include:

  • Regulatory Penalties: Failure to comply with safety reporting requirements may result in penalties from regulatory bodies.
  • Ethical Violations: Not reporting or properly handling AEs or SAEs can lead to violations of ethical standards and undermine the integrity of the research.

Non-compliance with this Safety Reporting Policy may result in disciplinary actions, including the removal of individuals from the research team or other actions as deemed appropriate by Anchor Medical Research LLC.

6. Policy Updates

This Safety Reporting Policy will be reviewed and updated regularly to ensure that it remains compliant with applicable laws, regulations, and best practices. Any updates to this policy will be communicated to all participants and stakeholders as necessary.

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