Easy review program for true clinical study data results! Learn to review Clinical Study Reports and check clinical data quality and clinical study progression yourself.
Are you a Clinical Research Professional or otherwise responsible to get quality clinical data in time and:
- Are you looking for a way to get insight in the quality of the clinical data results?
- Do you want to learn to review a Clinical Study Report more thoroughly by understanding and recalculating the presented tables and figures?
- Do you want to be able to see your contribution presented in raw data listings and clinical study results?
- Do you want to resonate better with clinical data management and statistics colleguaes?
The Easy review program for true clinical study data results learns you how to verify clinical data quality and clinical study progression yourself. And it takes you through thorough Clinical Study Report review.
Why could you use learning to review clinical data and presented clinical study results yourself?
Many clinical research professionals are not at easy in the area of their colleguaes from data management and statistics. Because your role is involved in the actual care at the study site, or more with the study management. But, all the clinical research roles involved in a study are there to deliver guaranteed quality clinical data. With such data, true conclusions and interpretations can be drawn as written in the Clinical Study Report. Because clinical data is part of all clinical research roles, I think you should be able to review your part reflected in the clinical study report and the raw data listings. And the good news, it can be easy done if you know how and where to look for.
So please, not only conduct your role, but also check if your output is reflected correctly in the final delivery of a clinical study. You are needed for a complete review of the Clinical Study Report. Not only an instant move to the final conclusions and interpretations for the drug, device under study... 'nice, interesting, OK, too bad. No, remember that you know what actually happened at the study site(s). Or in case of a more managerial role, you know how the study progressed in time. And take in to account, that the people mostly involved in all data, data managers, statistical programmers and statisticians only see the data at the office. The field, where the patients visit their care center, is not their first perspective. The data received, that's what they (only) work with. So you do have to contribute something to the review of a Clinical Study Report! Does it reflect the truth? What actually happened with the patients in the clinical trial?
The most considerate problems of people wanting to review clinical trial data are:
- not sure where to start their review of the Clinical Study Report
- not sure what to look for and what to focus up on for their specific contribution
- how to review
- insure about their capabilities to read raw data listings, read tables and graphs and read the text that leads to final interpretations and conclusions.
Does this have to stay this way? A clinical study report with all its appendices is for review within your reach.…
You too can:
- review the appendice with raw data listings
- recalculate descriptive statistics, descriptive statistics tables and frequency tables
- you do not need to be statistically educated. Your contribution is to review the clinical data on which those statistical tests are based.
- learn to quickly review large amounts of data. Judging clinical data quality status and clinical study progression yourself.
- learn to resonate with clinical data managers and / or statistical colleguaes on your professional area.
What do you need to be able to review clinical study results?
1. Raw data listings
All subjects, visits and measurements; all data listed and ordered.
2. A plan that moves from rough to detailed.
From first glance to recalculations.
3. The study objectives
Having clear what the study is about, what is important and what kind of quality level the clinical data requires.
You too can learn how to review clinical study results yourself with the Easy review program for true clinical study data results!
This program can help you:
- to check your contribution with the clinical study results
- to judge clinical data quality
- to keep track on clinical data progres
- to quickly review large amounts of data.
- to resonate with clinical data managers and / or statistical colleguaes on clinical study data
All clinical research professionals are involved in clinical data. Whether delivering it, collecting it, verifying it, grouping it, testing it, presenting it, managing it and initiating it. Thus assure that you review the clinical results from your unique professional perspective.
How does the program work?
- dosed study and practice material, background information and examples provided at intervals during the 6 week schedule. The material will help you learning to review clinical study results - and judge clinical data quality yourself.
- weekly e-mail support opportunity up on your clinical data results questions during the 6 week program duration.
- one personal telephone session to help you to advance in clinical study results review.
- one of your reviews in practice reviewed by ProCDM. What to look for? In which order?
The Easy review program for true clinical study data results! is a 6 weeks support program. You’ll need to invest at least 3 hours per week for study and contacts.
For more information or to check if this fits your review goals, just send an e-mail to info@procdm.nl with the subject "Easy review information".
Order form
Complete the form below to submit your application to the easy review program. The fields starting with an * are required for ProCDM to complete the invoice.
Please indicate if your company pays the program fee OR you invest in yourself.
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