Introduction
A single person may participate in a study multiple times. A common scenario for multiple participations is when a screening failure subject later goes through the screening process again in another attempt to enroll. There are also studies where a subject may participate more than once with more than 1 body part, such as a subject who participates with the left eye, and then enrolls again with the right eye. Some studies of rare diseases allow a subject to participate in and complete a study, and then later participate again. Subjects may receive different treatments in these different participations.
This does not affect ADaM unless there is an analysis need to report on the multiple participations. ADSL is required to contain only 1 record per subject, so it cannot be used with participation-level records. ADPL (Participation-Level Analysis Dataset) may be used to contain all participations per subject, with 1 record per participation (i.e. USUBJID SUBJID).
ADPL is a possible name for this dataset, instead of the possible name of ADDC (to mimic SDTM.DC), because it contains more information than just demographics as collected. ADPL is designed to include all variables that are included in ADSL, but with the addition of multiple rows per subject, when a subject has participated in the study more than once.
Advice/Instructions/Guidance
ADPL is one way to model participation-level data in ADaM; there may be other possible solutions.
ADSL remains as 1 record per subject, usually using the primary participation. It is up to the user to define the primary participation, whether it is a copy of a single record from ADPL, or some combination of the multiple participation records, based on analysis needs.
ADPL has the class ADAM OTHER, and it meets all ADaM conformance rules.
Other ADaM datasets can be merged with ADPL by USUBJID SUBJID to pick up the participation-level variables when the analysis requires inclusion of multiple participations.
Examples
SDTM.DC (Demographics for Multiple Participations), multiple records per subject
| Row | STUDYID | USUBJID | SUBJID | DCSEQ | RFXSTDTC | AGE | ARM | ARMNRS |
|---|---|---|---|---|---|---|---|---|
| 1 | AB-123 | AB-123-08 | 01 | 1 | 62 | SCREEN FAILURE | ||
| 2 | AB-123 | AB-123-08 | 08 | 2 | 2023-01-23 | 62 | Drug 1 | |
| 3 | AB-123 | AB-123-50 | 12 | 1 | 2020-01-24 | 70 | Drug 1 | |
| 4 | AB-123 | AB-123-50 | 50 | 2 | 2023-03-18 | 73 | Drug 2 | |
| 5 | AB-123 | AB-123-99 | 99 | 1 | 2023-04-01 | 65 | Drug 1 |
SDTM.DM (Demographics), 1 record per subject
The study team must decide how to populate the 1 record per subject in DM.
| Row | STUDYID | USUBJID | SUBJID | RFXSTDTC | AGE | ARM | ARMNRS |
|---|---|---|---|---|---|---|---|
| 1 | AB-123 | AB-123-08 | 08 | 2023-01-23 | 62 | Drug 1 | |
| 2 | AB-123 | AB-123-50 | 50 | 2023-03-18 | 73 | Drug 2 | |
| 3 | AB-123 | AB-123-99 | 99 | 2023-04-01 | 65 | Drug 1 |
ADPL (Participation-Level Analysis Dataset), multiple participations per subject
| Row | STUDYID | USUBJID | SUBJID | TRTSDT | TRT01A | ARMNRS | AGE | BLWT |
|---|---|---|---|---|---|---|---|---|
| 1 | AB-123 | AB-123-08 | 01 | SCREEN FAILURE | 62 | 55 | ||
| 2 | AB-123 | AB-123-08 | 08 | 23JAN2023 | Drug 1 | 62 | 57 | |
| 3 | AB-123 | AB-123-50 | 12 | 24JAN2020 | Drug 1 | 70 | 53 | |
| 4 | AB-123 | AB-123-50 | 50 | 18MAR2023 | Drug 2 | 73 | 46 | |
| 5 | AB-123 | AB-123-99 | 99 | 04APR2023 | Drug 1 | 65 | 50 |
ADSL (Subject-Level Analysis Dataset) based on ADPL
The study team must decide how to populate the 1 record per subject in ADSL, based on analysis needs. This team decided to keep the last participation per subject.
| Row | STUDYID | USUBJID | SUBJID | TRTSDT | TRT01A | ARMNRS | AGE | BLWT |
|---|---|---|---|---|---|---|---|---|
| 1 | AB-123 | AB-123-08 | 08 | 23JAN2023 | Drug 1 | 62 | 57 | |
| 2 | AB-123 | AB-123-50 | 50 | 18MAR2023 | Drug 2 | 73 | 46 | |
| 3 | AB-123 | AB-123-99 | 99 | 04Apr2023 | Drug 1 | 65 | 50 |
ADVS (Vital Signs Analysis Dataset), multiple participations per subject.
SDTM.VS has been merged with ADPL by USUBJID SUBJID to assign the correct TRTP (Planned Treatment) and ABLFL (Baseline Record Flag) per participation.
| Row | USUBJID | SUBJID | TRTP | PARAMCD | VISIT | AVAL | ABLFL | BASE | CHG | BASETYPE |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AB-123-50 | 12 | Drug 1 | PULSE | Screening | 60 | 62 | SUBNO1 | ||
| 2 | AB-123-50 | 12 | Drug 1 | PULSE | Cycle 1 Day 1 | 62 | Y | 62 | SUBNO1 | |
| 3 | AB-123-50 | 12 | Drug 1 | PULSE | Cycle 2 Day 1 | 63 | 62 | 1 | SUBNO1 | |
| 4 | AB-123-50 | 12 | Drug 1 | PULSE | End of Treatment | 62 | 62 | 0 | SUBNO1 | |
| 5 | AB-123-50 | 50 | Drug 2 | PULSE | Screening | 64 | 64 | SUBNO2 | ||
| 6 | AB-123-50 | 50 | Drug 2 | PULSE | Cycle 1 Day 1 | 64 | Y | 64 | SUBNO2 | |
| 7 | AB-123-50 | 50 | Drug 2 | PULSE | Cycle 2 Day 1 | 67 | 64 | 3 | SUBNO2 | |
| 8 | AB-123-50 | 50 | Drug 2 | PULSE | End of Treatment | 68 | 64 | 4 | SUBNO2 |
References and Resources
ADaMIG v1.3, Section 2.3.1
Dennis E, Fawcett G, Minjoe S. ADaM Datasets with Multiple Participations per Subject. PharmaSUG 2023 Paper SS-146. Accessed August 18, 2016.
Authors | ADaM Informative Documents Subteam |
Updated | 2026-08-18 |