Term | Definition | Explanation | Calculation |
Eligible | Meets the criteria for this study phase, and has not died or withdrawn before this study phase. | Eligible = Awaiting Follow-Up + Active Follow-Up | |
Awaiting Follow-Up | Participant is eligible but has not yet reached the minimum age for active follow-up | ||
Active Follow-Up | Participant is eligible and has reached the minimum age for active follow-up for this study phase. | Minimum age for active follow-up may be earlier than the minimum assessment age window eg if the planned assessment window is 23-25 months, active follow-up might start from 20 months. | Active Follow-Up = Withdrawn + Declined + In Progress + Lost + Not Assessed + Assessment Completed |
Reached Minimum Assessment Age | Participant is eligible and has reached the minimum assessment age | Defined for each study as the start of the planned assessment window eg 23 months for assessment window of 23-25 months. | Subset of Active Follow-Up |
Withdrawn | Participant has made an informed decision they do not want any further involvement in the study. | Participant should not be contacted again in the future. They should be asked whether they wish to be informed of the results at the end of the study. | Can have withdrawn before this study phase (thus not eligible) or after contact for this study phase |
Died | Can have died before this study phase (thus not eligible) or after the minimum age for active follow-up | ||
Declined | Participant has stated they do not want to take part in this phase of the study. | Participant is eligible to be contacted for future follow up. | |
In Progress | Actively being traced or assessed | In Progress = Tracking + Booked + Incomplete + Overseas | |
Tracking | Participant is being traced and consent is being sought | Subset of In Progress | |
Booked | Participant has consented and an appointment has been made. | Subset of In Progress | |
Assessment Incomplete (Commenced) | Participant has completed part of this phase of the study, but further data are expected. | E.g. Questionnaires still coming or waiting for a further appointment. | Subset of In Progress |
Overseas | Participant is overseas but has not declined and may still be assessed | Subset of In Progress | |
Lost | After all attempts, there are no positive leads regarding the participant’s whereabouts. | Unlikely to acquire data, although a further attempt may be made in the future. | |
Not Assessed | Data are not going to be available for this study phase | Eg past time window | |
Assessed Completed | All data that are expected for that participant have been collected. | Some elements of the data may still be missing, but they are not expected, and reasons for this will be recorded. May or may not have the minimum dataset. | |
Some Data Available | Some data is available for this participant. | Participant has consented and some elements of the data have been collected eg questionnaires. Some may still be coming. May or may not include the minimum dataset. | Percentage calculated as Some Data Available / Reached minimum assessment age |
Minimum Data Available | Minimum dataset as defined for this study is available for this participant. | Additional data may still be coming, or may already be collected .Minimum data will usually be what is needed to assess the primary outcome. | Percentage calculated as Minimum Data Available / Reached minimum assessment age |
Follow-Up Coordinator Report
Participants | In Progress | Assessment Status | Data Status | |||||||||||
Active Follow-Up | Reached Minimum Assessment Age | Total | Tracking | Booked | Incomplete | Overseas | Withdrawn | Died | Declined | Lost | Not Assessed | Assessment Completed | Some Data Available N (%) | Minimum Data Available N (%) |