To join the Epi25 collaborative:
Make sure to check out the eligibility criteria here.
Review and sign the Epi25 Charter and send by email to Cate Freyer
Review the inclusion/exclusion criteria and the Epi25 protocol. Please note that the protocol is not an IRB-approved document.
To send samples to the Broad Institute for whole exome sequencing:
Review and attest agreement by email to the Epi25 MOU.
Send a copy of the blank consent form(s) used to collect your samples to the Broad Institute.
Submit Data Use Limitations letter templates (DULs) to your IRB for them to complete. The DULs should attest that the consent form(s) allow for broad sharing and data deposition and to specify any data use restrictions. This cover letter describes the data use letter requirement; this file is used for samples collected before 1-25-2015; this file is used for samples collected after 1-25-2015. When completed, please send these forms to the Broad Institute.
Determine if a MTA is required by your institution for the sample transfer to Broad. For EU sites, determine if the DNA samples and data that you will send to Broad are considered “personal data.” If yes, please provide a draft EU Standard Data Protection Clause.
Confirm number of DNA samples available that meet the inclusion criteria and that volume and concentration requirements (80 ng/ul; 50 ul of whole blood or saliva -derived DNA) are met. Broad Institute requirements for sequencing are detailed here.
Complete the New Collection Request Form to request Broad DNA Matrix kits to send your samples to the Broad.
Please send all completed Broad forms and required documents to Felecia Cerrato at the Broad Institute.
To enter your clinical data into the Epi25 REDCap database:
Entry of phenotypic data is required for all samples sequenced as part of Epi25. The phenotypic data (forms online here) is a set of critical data elements that is usually a subset of the research data collected on behalf of the original collaborator's research project or in the participant's research record.
Make sure you know your Epi25 site identifier, which will be assigned to your site once you have joined the collaborative, since your Epi25 subject ID will be comprised of your Site ID + your local subject ID. For example, for EPGP, the site ID is USAEGP and the subject ID is EPGP0001, so the Epi25 ID is USAEGPEPGP0001.
Some collaborators have most of this phenotypic data in a structured database and can import the data directly into the Epi25 database. If you have clinical data in a structured database, you can send your data directly to Kevin McKenna.
Other collaborators enter their data directly into the RedCap phenotypic forms (forms online here ) from the participant's research records. If you need access to RedCap, please email Roland Krause. Please always use institutional e-mail addresses and obtain a login for every user accessing the database.
To use Epi25 data:
Now that data analyses are underway, the Strategy Committee, Analysis Committee, and Executive Committees have worked to harmonize the charter into a protocol for new research proposals using Epi25 data. Investigators who wish to use the Epi25 data set should: