for instance :
Parallel design :
|-----------------------> SUBJECT:101 DRUG : A (RFSTDTC) (09/25/2018)
|
DRUG X -----------------|
(RFXSTDTC) |
(09/23/2018) |-----------------------> SUBJECT:102 DRUG : B (RFSTDTC) (09/25/2018)
SUBJECT :101,102
* In the above example, Drug X is given for both subjects (101,102) for 2 days, after they randomized to drug A , Drug B as per study design.
* Please find A screen shot from SDTM Implementation Guide.
* RFXSDTC : Any protocol specified drug date and /or earliest drug exposure date (DRUG X - Can be placebo or cleaning medication or anything it depends )
*RFSTDTC : Subject first exposed to study treatment (Main drug : DRUG A ,DRUG B) .
* This is what I interpreting from IG which make sense to me but this can be wrong. Please ask some expert advisor for more clarity on this.
/******************************************************************************************************************************************/
It usually never happens but for instance, Subject 101 ,Let's carry forward previous example, assign to "DRUG X + DRUG A" but by mistake he/she got "DRUG X + DRUG B" bottle. OR Subject 103 ( I put new subject for example) is screen failure due to some reason ( not show up at clinic after randomization). We assign him/her to get Drug X + Drug B but he/she Screen Failure. so Now this we can
put like this :
SUBJNO ARM ARMCD ACTARM ACTARMCD
101 Drug X + Drug A XA Drug X + Drug B XB
102 Drug X + Drug B XB Drug X + Drug B XB
103 Drug X + Drug B XB Screen Failure SCRNFAIL
PS
