Perelman School of Medicine at the University of Pennsylvania

Gelfand Clinical Research Lab

FAQ

How long is the trial/program? What is the length of my commitment?

Your commitment will be 12 months long (in terms of collecting data from patients). We may be able to extend this if we get more funding, etc.

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I understand the data entry will take about 15-20 minutes for each patient. Is this correct? How often are patients seen in the study?

Patients are seen once only. If they refuse to participate and then come back to clinic they are excluded. Data collection varies depending on how complicated the patient’s history is – generally speaking – face to face time with the patient and your coordinator will be 15-20 min max, your face to face time beyond your usual visit takes only an extra few minutes (to do a PASI and PGA) the coordinator will likely have another 15-20 min behind the scenes time (prepping charts, entering data).

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Do we follow up with patients any other way other than interval visits (i.e., are there phone interviews, patient logs to track/enter, specific labs to track, etc.)

No

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Is there an equipment budget (i.e., funds for computers or software that might be required)?

No but if there is software you need we will try to obtain it for you.

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Am I still billing patients’ insurance for the visits?

Yes – this is strictly observational.

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How do I get paid and how often?

We will generate an invoice for you quarterly based on the number of points that have clean data (i.e. Queries are resolved) and number of teleconferences you attend.

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Is there money for adverse events?

No – the patients are not followed, there are no adverse events (although if a patient has a complaint re: the study, this should be communicated to Dr. Gelfand).

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Are there trial monitors that will visit periodically? Investigator meetings?

There will be a site training by telecon for your staff, a telecon for data entry training for your staff, a telecon for you with Dr. Gelfand (and your staff if you’d like), and then a monthly investigators TC which occurs the first Monday of the month at 2 PM EST or the last Friday of the month at 3 PM EST (you can choose the one that is better for your schedule – if neither works, please let Dr. Gelfand know) – they last about 20 min to 60 min max.

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I have resolved the discrepancies regarding the BSA and PASI. I had entered just 0 for the BSA where appropriate and when that fired a discrepancy I put in clear and then it looked like it was resolved at my end because the “red person” cleared. I then realized what is needed is 0.0 to be entered to avoid a discrepancy so that is how I corrected the others and entered the patients for today and all was fine.

You will need to enter the palms to one decimal. Please make sure those measuring the PASI entered all assessments to one decimal to accommodate for small amounts of skin involved. So results might be 3.5 palms for the head, 0.5 palms for the arms, 1.2 palms for the trunk, and 5.0 palms for the legs.

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I did get a discrepancy fire today on # 3006 on the current systemic page. Under MTX it is asking if this was used with folic acid. This patient is not currently nor was she ever, on MTX so information was never entered for this treatment. I’m not sure why the discrepancy fired or how I should resolve it.

We are aware of the errors flagging on the medication forms and are working to resolve them. When doing data entry on any of the medication forms, please check the “blank form” box in the right upper hand corner for any sections/medications that do not apply for a particular subject. This will trigger the system to avoid looking for any discrepancies in that section.

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I work on Saturdays sometimes and when I was here this past Saturday I tried to log in to enter data on a Friday patient that was enrolled, # 3005. I got a message that said there was an internet connection problem. I don’t think it was at our end because I was able to log in to EDC systems for other studies to enter data, will I normally be able to enter data on Saturdays?

The system is typically available 24/7 however there was an issue with a server this past weekend which made it difficult for some folks to connect. The issue was resolved yesterday and you should not have any trouble with access now. Please let us know if/ when you have problems in the future. You can contact the CRCU helpdesk (contact information below).

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The system is typically available 24/7 however there was an issue with a server this past weekend which made it difficult for some folks to connect. The issue was resolved yesterday and you should not have any trouble with access now. Please let us know if/ when you have problems in the future. You can contact the CRCU helpdesk (contact information below).

They can be included but would be flagged in the database (i.e. there is an option for stating who the primary prescriber is and the primary indication).

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