Plans to promote participant retention and complete follow-up

Every effort will be made to ensure participants adhere to the follow-up. If the participant is unable to return for an onsite clinical visit or have a follow-up phone call, the Investigator or qualified designee must document the reason, and make reasonable effort to obtain the information from the participant otherwise.

A participant is considered lost to follow-up when contact with the participant has been lost without completing the final assessment at the end of the 2-year follow-up period, and every attempt to contact has failed. At least 3 documented attempts must be made to contact the participant at each follow-up timepoint. Collection of any available data or vital status, either at the interventional center, at the referring hospital, with the general practitioner, or the municipal registries continues. Information regarding all attempts to contact the participant are documented and an end of study form must be completed. Participants who are lost to follow-up will not be replaced.

Participants who explicitly disallow further clinical follow-up and data collection are considered “withdrawals”. If a participant disallows further collection of study data, their data are evaluated until then. The investigator will make a reasonable effort to ascertain the reason(s), while fully respecting the participant’s rights. If available, the reason is recorded, and an end-of-study form is completed. Participant-specific data on the basis of material obtained before withdrawal may be generated after withdrawal (e.g., image reading, analysis of blood sample); these data will also be retained and statistically analyzed in accordance with the statistical analysis plan.

All data entered into the EDC has source documentation available at the site. There is also a comprehensive and centralized file (Investigator Site File) of all study-related essential documentation, suitable for inspection at any time by representatives from sponsor and/or applicable regulatory authorities. Only authorized personnel, auditors and monitors have access to the study data. Clinical data management is performed in accordance with applicable Contract Research Organization’s (CRO’s) standards and data cleaning procedures (Cardialysis, B.V.). Additionally, each clinical site performs internal quality management of study conduct, data and biological specimen collection, documentation and completion. Quality control procedures are implemented beginning with the EDC and data QC checks that are run on the database. Any missing data or data anomalies are communicated to the site(s) for clarification/resolution. In addition, monitoring visits and possibly audits and inspections ensure oversight of the full quality control process.

All information identifying the patients will be kept confidential and will not be supplied to the public. Names of the participants will not be made available to the sponsor. Only the participant’s identifying number will be recorded in the EDC, and in case the participant’s name appears on any document, including angiograms, IVUS, or ECG, it must be obliterated before a copy of it is made available to the sponsor. Additionally, all images sent to Steering Committee or delegates for feedback are pseudo-anonymized and include only the patient’s date of birth. Any other information that can identify the patient is removed. All study findings are stored in computers according to the local data protection laws. In case the study results are published, the participants’ identities will remain confidential. However, the investigator is allowed to maintain a list to enable participants’ identifications. For the purpose of the study, it is necessary to be able to trace data to the individual participants for 15 years, and thus, a participant identification code list will be available to link the data to the participants. The code will not include the participants’ initials, and/or birth date. The key to the code will be safeguarded by the Investigator. Personal data handling will follow the EU General Data Protection Regulation and the national regulations.