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
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