1.Please select all that apply

I am a physician

I am a nurse

I am a clinical research professional (PM/CRA/CTA/Monitor/Research coordinator/Other)

I am an industry representative

I am a regulator / regulatory expert

I am a statistician

Other

2.Are you familiar with the difference between a patient registry and a registry-based study?

Yes

No

3.Please tick all that apply

I am familiar with the EMA Guideline on registry-based studies (adopted on September 2021)

I am familiar with the USA FDA Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (adopted on August 2023)

I haven't read these documents

4.Are you currently involved in the execution of a patient registry?

Yes

No (Jump to question 8)

5.Is informed consent obtained from patients entering the registry?

Yes

No

6.Which are the objectives of the registry or registries you are involved with? (tick all that apply)

To further study clinical effectiveness of a drug or device

Safety surveillance

Understanding the natural history of a disease

Evaluation of quality of care

Other

7.Select from the list below the most important hurdle in the implementation of patient registries? Tick more than one if needed.

Workload (i.e. time required for data entry)

Quality of data is insufficient

Lack of databases interoperability

Difficult ethical or institutional approval

Funding

8.What is your impression of data quality in patient registries for its use in regulatory pathways?

As good as clinical trials

Not as good as clinical trials, but acceptable

Insufficient and not acceptable

9.Which is the best patient registry example you are familiar with? (Optional)

10.If you would like to learn more about initiatives around cardiovascular registries, please enter your email below.