topic Re: Clinical SAS Questions in SAS Health and Life Sciences

Clinical SAS Questions

_ra_ — Fri, 13 Apr 2018 07:05:20 GMT

what is the purpose of DMDTC in sdtm

I want know what is randomization number is it present or not ??.

difference between RFSDTC & RFXSDTC.

Re: Clinical SAS Questions

RW9 — Fri, 13 Apr 2018 08:16:47 GMT

These are questions to do with CDISC data modelling, nothing to do with SAS at all. Please use the appropriate CDISC forum.

Re: Clinical SAS Questions

shahparth260 — Sun, 12 Aug 2018 02:28:58 GMT

what is the purpose of DMDTC in sdtm

I want know what is randomization number is it present or not ??.

difference between RFSDTC & RFXSDTC

/***********************************************************************************************************************/

1) DMDTC : DMDTC is USUALLY the date when Demographic information collected on CRF.

2) Randomization Number you may find many times, which is also known as RANDSEQ or Randomization Sequence No. or Keycode

Here's Good Example:

Rawdata.Demog

SUBJID KEYCODE AGE SEX

001 2101 38 M

002 2202 29 F

003 2101 24 F

Rawdata.Keycode

KEYCODE ASSINGED DRUG

2101 ZXP-009

2202 PFZ-9220

SDTM.DM

SUBJID KEYCODE AGE SEX ASSINGED DRUG

001 2101 38 M ZXP-009

002 2202 29 F PFZ-9220

003 2101 24 F ZXP-009

3) RFXSTDTC vs RFSTDTC

a) RFXSTDTC : Reference exposure start date when ANY drug is started to given to subject, in many trials you may find Placebo (blinded) is given in Run-in phase and after day 1 Treatment starts (main drug/placebo),in this case start date of placebo in Run-in period.

b) RFSTDTC : Usually this date is Refrence period start date (means analysis time period) after first date of main dose. DAY 1 or first treatment date,

I hope it helps you.

Please let me know if someone thinks this is not correct.

Comments and suggestions are welcome.

tapswi2696@gmail.com

Re: Clinical SAS Questions

srikanth4evrps — Fri, 21 Sep 2018 20:19:45 GMT

Pls give rfstdtc vs rfxstdtc with examples....and arm actarm with examples
Regards
Srikanth

Re: Clinical SAS Questions

shahparth260 — Mon, 24 Sep 2018 07:47:11 GMT

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

Re: Clinical SAS Questions

RW9 — Mon, 24 Sep 2018 07:50:10 GMT

As above, this is CDISC modelling questions, not SAS related. Refer to the CDISC forums:
https://www.cdisc.org/forum

Re: Clinical SAS Questions

shahparth260 — Mon, 24 Sep 2018 08:02:29 GMT

Respected @RW9 ,

I will assure you to not give answers for CDISC model here but question asked by novice users that's why explained,

I totally agree this is not right place to ask CDISC questions.

Re: Clinical SAS Questions

srikanth4evrps — Mon, 24 Sep 2018 08:03:37 GMT

Thank u .....

Re: Clinical SAS Questions

sharathbairoju — Sun, 10 Mar 2019 07:05:26 GMT

hi ,

what is RFPENDTC and how to derive it.

Re: Clinical SAS Questions

RW9 — Mon, 11 Mar 2019 10:16:16 GMT

Please do not tag additional questions onto old questions.

Also note this forum is for SAS programming, not discussions of CDISC modelling.