Study identification

EU PAS number

EUPAS21151

Study ID

23298

Official title and acronym

Pregnancy Prevention Program Section of the Risk Management Plan for Soriatane® (acitretin): Survey to Assess Physician and Pharmacist Understanding of the Risk of Teratogenicity Associated with Soriatane

DARWIN EU® study

No

Study countries

Canada

Study description

This is a one-time survey study of Canadian physicians and pharmacists. Two separate survey questionnaires will be developed for physicians and pharmacists, respectively. 1. The Pretest Phase Survey pretesting is used to evaluate the readability and interpretation of each survey comprehension question. This involves pretesting and functionality testing of the internet-hosted survey tool, including the electronic data-capture system. In addition, the pretesting is performed to determine if any question performance problems are related to clarity of wording versus respondent understanding. 2. The Full Launch Phase The study procedure will consist of recruiting prescribers and dispensers of Soriatane in Canada to participate in a voluntary online survey. The expected duration of the survey fielding will be 8-12 weeks.

Study status

Finalised
Research institutions and networks

Institutions

Analysis Group Inc

Contact details

Bai Yan

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Allergan/Arelaz
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only