CRIS Tips - Click here to download this guide put together by DCRI. The following topics are covered in this guide:
Additional reference materials can be found on the DCRI website.
A summary of the registration types, required documentation, and business rules for RCR is provided in the table below. Links for RCR registration and information include:
You will need to update the account once a year.
Landing page: https://cc.nih.gov/followmyhealth/index.html
Slides with screen shots from FollowMyHealth, click here.
Order Sets - Steps to create/modify/delete an orderset
Step 1: Go to https://clinweb.cc.nih.gov/DCRIRNA/OrderSet and make changes.
Step 2: Complete a DCRI Request Form: https://cris.cc.nih.gov/pdfs/dcri_request_form.pdf
Step 3: Drop off the form in the DCRI office or email the form to: CC-DCRIProtocolOrderSetTeam@mail.nih.gov
PHI - Please do not include PHI in documents sent to CCRSafety, on MedWatch forms, or any supporting documents. All documents need to be de-identified. That includes: patient initials, birthdates, SSN, hometown, phone/fax numbers, medical record or account numbers, protocol numbers, etc. For a comprehensive list, here is a link to a UC Berkeley site for PHI: http://cphs.berkeley.edu/hipaa/hipaa18.html
You may use the patient ID in the first box on the MedWatch. Use the same patient ID when you name files. For the patient ID—use the unique ID number that is assigned by the sponsor at enrollment, be that via C3D, OPEN/IWRS or another registration system, or the Sponsor (if not the CCR). For example, patient #1 would be 1010001. (The problems arise if you use the patient ID and some part of the patient’s name to name a document.). Outside sponsors usually have their own SAE reporting form, in which case you would not be using the MedWatch 3500a.
Redact tools in Adobe - Need help with removing PHI from PDFs? Adobe has a step-by-step guide that can help you.
SEFT, MSE, PIV Encryption, FMH, SHM
Secure communications to non-NIH staff/collaborators electronically that involve PII and/or receiving/transferring large documents. Does not require a PIV card, thus making it available to NIH staff with AD accounts who cannot be issued a PIV (e.g., short term appointment, volunteers). The system is not to be used for communicating patient care with outside physicians.
When communicating with patients, the approved methods of communicating electronically is the MSE tool and SHM. We prefer the use of SHM. View information regarding the secure email process (e.g. policy, consent, registration process, and reference material including an online tutorial).
Secure electronic communications w/ NIH staff using NIH PIV card encryption in Outlook
Select the Encrypt option on the Message tab of an open email message w/ PIV card inserted into computer and enter PIN; both users need to be PIV enabled
Patients may now receive messages from NIH Staff through the FollowMyHealth® portal.
When communicating with patients, the approved methods of communicating electronically is the MSE tool and SHM. We prefer the use of SHM. Using the CRIS Secure Health Messaging application, patients will receive messages through the FollowMyHealth® portal.
Select 'Open Secure Health Messaging...' in the CRIS Application