Risk Specify concerns Can the risk be minimised? Could monitoring methods Specify help to address concerns? Right heart Risk of complication: sites experienced with Data Safety Monitoring catheterisation Excessive e.g. bleeding, the procedure Committee convened pneumothorax Contact details of a clinical On-site adverse advisor in protocol monitoring checks to participant rights from failure to obtain appropriate consent Risk Specify concerns Can the risk be minimised? Could monitoring methods help to address concerns? Consent Procedure: Children between 4 and Study team with paediatric Central monitoring of Vulnerable population 10 years) expertise consent by trial centre Specific training on the (with statement in the Failure to obtain consent/assent process information leaflet to informed parental Age appropriate information ensure explicit consent for consent leaflets reviewed by a patient this activity) group for levels of clarity and understanding Risks to participant rights from failure to protect their personal data Risk Specify concerns Can the risk be minimised? Could monitoring methods help to address concerns? Breach of Identifiable data Confidentiality agreement in Patient consent sought - confidentiality transferred out of place between the hospital and An explicit statement that South Africa the institution undertaking the data processing will take analysis place is added in the Computer security systems Patient Information assessed Leaflet Risk to the reliability of results Risk Specify concerns Can the risk be minimised? Could monitoring methods help to address concerns? Strict eligibility criteria Increased risk of Central review of eligibility prior Annual monitoring visit to and complex study ineligible patients to randomisation by include checks of clinical requirements being entered/ faxed form records of protocol violations with key de-identified data eligibility/endpoint data Annual investigator Protocol-specific training meeting with issue delivered at meeting resolution session and top-up training Document history: Version No. Date Reviewer Details of changes
Risk Specify concerns Can the risk be minimised? Specify Could monitoring methods help to address concerns? Right heart catheterisation Risk of complication: Excessive e.g. bleeding, pneumothorax sites experienced with the procedure Contact details of a clinical advisor in protocol Data Safety Monitoring Committee convened On-site adverse monitoring checks to participant rights from failure to obtain appropriate consent Risk Specify concerns Can the risk be minimised? Could monitoring methods help to address concerns? Consent Procedure: Vulnerable population Children between 4 and 10 years) Failure to obtain informed parental consent Study team with paediatric expertise Specific training on the consent/assent process Age appropriate information leaflets reviewed by a patient group for levels of clarity and understanding Central monitoring of consent by trial centre (with statement in the information leaflet to ensure explicit consent for this activity) Risks to participant rights from failure to protect their personal data Risk Specify concerns Can the risk be minimised? Could monitoring methods help to address concerns? Breach of confidentiality Identifiable data transferred out of South Africa Confidentiality agreement in place between the hospital and the institution undertaking the analysis Computer security systems assessed Patient consent sought - An explicit statement that data processing will take place is added in the Patient Information Leaflet Risk to the reliability of results Risk Specify concerns Can the risk be minimised? Could monitoring methods help to address concerns? Strict eligibility criteria and complex study requirements Increased risk of ineligible patients being entered/ protocol violations Central review of eligibility prior to randomisation by faxed form with key de-identified data Protocol-specific training delivered at meeting Annual monitoring visit to include checks of clinical records of eligibility/endpoint data Annual investigator meeting with issue resolution session and top-up training Document history: Version No. Date Reviewer Details of changes