This textbook was written for the clinical research community at Johns Hopkins leveraging the precision medicine analytics platform (PMAP). These notebooks are available in html form on the Precision Medicine portal as well as in computational form in the CAMP-share folder on Crunchr (Crunchr.pm.jh.edu).

Before you start cooking

Table of contents

Do you need an IRB to access PMAP?

You do not need to have an active IRB protocol in order to access the de-identified CAMP database for the purposes of learning about the PMAP toolset.

If you plan to use PMAP to conduct clinical research, then you must have an approved IRB protocol that explicitly mentions your use of PMAP as part of that research activity. If you are uncertain as to whether your use of PMAP is considered research, read the following policy.

Hopkins IRB Policy

When in doubt, it is a best practice to submit a protocol for review so that the IRB can determine whether or not your proposed activity constitutes clinical research and if so, what type of review is appropriate.

What type of protocol should I submit for my research use of PMAP?

If you are planning to create a new registry in PMAP for your research (such as a disease-based registry), then you will need to complete and submit an eFormR to the IRB for this new resource. Otherwise, consult this website to find the form that best fits your study protocol. https://www.hopkinsmedicine.org/institutional_review_board/forms/index.html

Do I have to get Data Trust approval to use PMAP?

If you are working exclusive in PMAP and the SAFE, with no data leaving PMAP/SAFE, and if you are not accessing any sensitive data then it is unlikely that you will be asked to get Data Trust approval. The PMAP is considered a Tier A environment which is the most secure and thus lowest risk. You can read more about Risk Tiers here . When preparing your IRB protocol you will be asked some questions which will determine your Risk Tier

How can I tell what data are available in PMAP?

To see what data sets are available, look at the PMAP Data Catalog.