Bioequivalence and Bioavailability Forum • Software for subject randomization

TK
☆

Thailand,
2017-10-04 13:49
(2755 d 17:13 ago)

Posting: # 17849
Views: 6,880

Software for subject randomization [Software]

Dear All,

Could you please give me an advice for the software use for subject randomization?

and Where can we get it from?

We will need the one that can be validated.

Now, we do randomization by using the webpage, capture screen for the evidence but our clients said it cannot be traceable and not validated.

Is it possible if we would like to continue doing this? If yes, What the additional steps need to be done?

Thanks a lot!

TK

Edit: Category changed; see also this post #1. [Helmut]

Helmut
★★★

Vienna, Austria,
2017-10-04 14:02
(2755 d 17:01 ago)

@ TK
Posting: # 17851
Views: 5,857

package randomizeBE for R

Post reply

Hi TK,

I recommend Detlew Labes’ package randomizeBE for

. Yung-jin added a GUI to his package bear. For details see this post.

Example using the defaults (crossover with sequences TR|RT, blocksize = 2× number of sequences):

library(randomizeBE) RL4(nsubj=12) Randomization table created: 2017-10-04 12:02:21 (seed: 956888 blocksize: 4 ) subject seqno sequence 1 1 TR 2 2 RT 3 1 TR 4 2 RT 5 2 RT 6 1 TR 7 2 RT 8 1 TR 9 1 TR 10 2 RT 11 1 TR 12 2 RT

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

TK ☆ Thailand, 2017-10-05 13:36 (2754 d 17:26 ago) @ Helmut Posting: # 17862 Views: 5,578	package randomizeBE for R Post reply
	Hi Helmut, Thanks so much for your promptly response. Greatly appreciate it! We will try to work on it. Sincerely, TK Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

DavidManteigas
★

Portugal,
2017-10-06 12:28
(2753 d 18:35 ago)

@ TK
Posting: # 17865
Views: 5,705

SAS proc plan

Post reply

If you already use SAS for statistical programming, you may consider using PROC PLAN to generate the randomization list. You can keep SAS Log after executing the code and store as evidence. But the best way to have randomization properly performed, regardless of the software, is to have a SOP implemented which allows the proper documentation of the process, including the randomization specification and approval.

d_labes
★★★

Berlin, Germany,
2017-10-06 22:13
(2753 d 08:49 ago)

@ DavidManteigas
Posting: # 17869
Views: 5,589

SAS proc plan

Post reply

Dear David,

❝ If you already use SAS for statistical programming, you may consider using PROC PLAN to generate the randomization list.

That's one of the ugliest PROC I have ever seen. Call that guy which has mastered it a SAS hero ;-)

❝ ... But the best way to have randomization properly performed, regardless of the software, is to have a SOP implemented which allows the proper documentation of the process, including the randomization specification and approval.

Full ACK! Even if you describe in that SOP that you perform your randomization by drawing lots out of the hat.
BTW: One of the best randomization procedure if you ask me. As you can see every week in the lottery. Although there they dont use hats.

—
Regards,

Detlew