SOP for Safety Monitoring and Reporting Procedures

PURPOSE

To define procedures for monitoring participant safety and taking action in response to potential safety concerns in XXX.

SCOPE

This standard operating procedure applies to all study staff involved in XXX.

RESPONSIBILITIES

• All XXX staff members are responsible for following this SOP.
• YYY is responsible for training XXX staff to follow this SOP and for day-to-day oversight of study staff to ensure that this SOP is followed.
• XXX Investigator of Record (IoR) is ultimately responsible for ensuring that all XXX study staff follows this SOP.

PROCEDURE

1. Safety Follow-up Procedures

In accordance with their training, qualifications, and designated study responsibilities, clinical staff will assess potential medical safety and social harm issues affecting participants. Social harms are defined as non-medical adverse consequences that occur as a result of the participants’ involvement with the study. Clinical staff members will identify appropriate follow-up, treatment, and/or referral requirements in the event that safety concerns arise, whether medically or socially related. If study staff members do not have sufficient knowledge or skills to adequately assess a participant’s medical or social issues, they will contact their supervisor for advice or assistance, with the IoR being ultimately responsible for ensuring adequate and appropriate clinical management of all participants.

• Any medical or social harm emergencies will be managed per the site emergency response plan.
• Adverse events (AEs) will be clinically managed per XXX protocol and XXX SSP manual. AEs will be documented and reported per protocol and SSP. Study product will be managed in response to AEs according to XXX protocol.

1. In the rare event that clinical staff members determine that appropriate follow-up requires deviation from the XXX protocol, the rationale for the deviation will be documented in chart notes and approval will be obtained from the IoR or designee. Except in emergency situations, when an immediate decision is needed to protect participant safety, the IoR or designee will consult with the PSRT and the XXX Regulatory Department before approving the deviation. The IoR or designee should also alert the study management team that this has occurred.

• Other medical issues and all non-emergency social harm issues will be managed per usual standards of care for medical practice in the study site locale and in accordance with the XXX protocol and SSP Manual.

1. Per protocol, social harm assessment should be conducted quarterly and at the product use end visit (PUEV), but social harms should be reported to SCHARP at any point that a participant discloses this information throughout the duration of the study.
2. When issues are beyond the scope of services that can be provided through the study, study staff will refer participants to appropriate non-study health care providers or social service provides for further follow-up. At each study visit after a referral is made, clinical staff will follow-up on the referral to determine whether the participant sought the services to which she was referred, determine the outcome of the referral, and determine whether additional referrals are needed.

• In the event that medical or social harm issues are reported during a study visit to study staff members who are not trained to respond to the issues, [describe communication/reporting process to clinical team members here].
• In the event that medical issues or social harms are reported to study staff off-site (e.g., during outreach activities) who are not qualified to respond to the issues, [describe communication and reporting process to clinical team members here. Combine with above point if appropriate].
• All medical issues and social harms will be followed to resolution or stabilization, with the current status and further action plans (if applicable) documented at each study visit until resolution or stabilization occurs. “Resolution” is defined as returning to the condition or severity grade that was present at the time of randomization. “Stabilize” is defined as persistence at a certain severity grade for three consecutive monthly evaluations. Follow-up on issues once the participant terminates will be conducted per SSP Section number.
• AEs that are ongoing at the end of the study will be managed per Section of the SSP. [Add site-specific processes or procedures for continued management or follow-up, if different than what is described in section above.]

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2. Tracking and Documentation

• All adverse events experienced during the study will be documented on either the AE-1 CRF or the GAE-1 CRF, as appropriate. Each ongoing AE must be followed up until resolved or stabilized. [Insert responsible staff] must reference these CRFs at every clinic visit to ensure ongoing AEs are appropriately tracked and followed up on.
• All social harms related to study participation should be documented at the time of the report using the Social Impact CRF and faxed to SCHARP. Throughout study participation all ongoing social harms reported by the participant will be followed up on until they are resolved.
• In the event that study participants are hospitalized or otherwise treated by a non-study health care provider, every effort will be made to obtain copies of relevant medical records. [Insert responsible staff] will oversee these efforts and all efforts will be documented in chart notes.

3. Internal and External Reporting

• [Insert responsible staff] will report any urgent safety concerns to [Insert responsible staff] and/or the IoR, who will consult with the PSRT per protocol and as needed. All PSRT consultations will be documented in participant study charts by printing and filing PSRT emails, or the final PSRT query form which includes the response from the PSRT.
• Participant safety information, including any unanticipated problems related to study participation, will be reported to the [specify names of relevant site ethics and regulatory authorities] per [Site SOP XXX on IRB Communication]. [Describe how safety information will be reported to these bodies and frequency of reporting unless the IRB Communication SOP already specifies this].
• Related specifically to adverse event (AE) reporting:

1. Guidance on AE reporting can be found in Section of the SSP.
2. The Adverse Experience (AE-1 and GRE-1) and Social Impact CRFs will be completed per Section of the XXX Study Specific Procedures Manual (SSP) and the Data Management SOP XX. Responsible staff will complete these CRFs. [Describe site review process for AE CRF, including QC review and timing to ensure Data Fax timelines are met].
3. Expedited adverse event (EAE) reports will be submitted to the Division of AIDS Regulatory Support Center Safety Office as is stated in the XXX protocol. For events that meet EAE reporting criteria:
4. Responsible staff will prepare the EAE report using the DAIDS Adverse Experience Reporting System (DAERS), per the DAERS Reference Guide for Site Reporters and Study Physicians.
5. Before submission of the report, responsible staff will compare it with CRFs completed to document the same event, to ensure consistency between the EAE report and the CRFs.
6. Responsible staff will submit the EAE report via DAERS within 3 reporting days of site awareness that the event met EAE reporting criteria.
7. Responsible staff will generate a printout of the submitted EAE report and file it in the participant’s study chart.
8. A confirmation of receipt should be received after the EAE report is submitted. If confirmation is not received within 1 business day, responsible staff will contact the Safety Office by phone or email to determine whether the report was received. If not, the report will be re-submitted. Once received, responsible staff will print the conformation and filed it in the participant’s study chart with the printout of the submitted report.

In the event that DAERS cannot be accessed within the three-day timeframe, paper-based EAE reporting will be completed to ensure this timeline is met, per instructions in the Manual for Expedited Reporting of Adverse Events to DAIDS.

4. Quality Assurance

• Responsible staff will routinely review random selections of participant charts to ensure that protocol specifications related to participant safety are being followed and that appropriate clinical and social harm management is being provided and properly documented. [Specify frequency of reviews and number/percentage of charts that will be reviewed; or reference site CQMP or other SOP if this information is captured elsewhere].
• Describe the QA process that will take place for all participants experiencing SAE/EAE to ensure proper management and documentation- including who will conduct this review, how frequently it will be conducted, how it will be documented and how findings will be communicated to relevant staff members.

REFERENCES

• Protocol
• SSP Manual
• The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0
• Addendum 1-Female Genital Grading Table for Use in Microbicide Studies
• DAERS Reference Guide for Site Reporters and Study Physicians.
• Manual for Expedited Reporting of Adverse Events to DAIDS.

REVISION HISTORY

Nil

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