When EDC is used in a clinical trial, electronic case report form (e-CRF) data are defined to be the data that are manually entered into a computer by the patient or by the investigator’s staff.
CDISC defines e-CRF as a CRF in which related data items and their associated comments, notes, and signatures are linked electronically.
e-CRFs may include special display elements, electronic edit checks and other special properties or functions used for both capture and display of the linked data.
Prior to submitting a request – FastStart, you should throughly test your trial.
Technically speaking, FastStart requests ensures base is cooked when sending all UAT versions of the trial, Training and Production versions of the trial to Oracle implementation team. This will vary on the type of contract your company / sponsor has with them.
Your company or sponsor may have a setup of ‘Implementation’ instructions that will be provided to Oracle HSG (formerly PhaseForward) that includes all files, summary and instructions for each implementation. Some of these required files or special files are listed below.
|Customresources.XML||Collects references to any html files that will be use to override standard InForm functionality within the trial. Includes the visit calculator (VISITCALCULATOR.HTML) and confirmation of enrollment message (ENROLLMENTCONFIRM.HTML).|
|InsertSiteGroups.XML||Links users with specific sites|
|InsertGroups.XML||Defines the properties and contents of groups e.g. queries, items|
|InsertRightsGroups.XML||Groups multiple access rights, with details of specific users that are assigned those rights.Also contains details of any overrides to default levels of access at item level|
|InsertSignCRF.XML||Defines form to be signed and group who have access to sign|
|Crbaffadavit.TXT||Affadavit text which appears when signing the eCRF (used at eCRF level). The text is standard, but protocol number must be amended for each trial. NOTE: This file will be used for any trials using casebook level signatures.|
|logo.jpg||Your company logo|
|EnrollmentOverride.htmlHomedefault.html||Here you can modify your trial name|
The eSignature is a replacement for the Investigator’s physical signature (paper form). This file captures confirmtion from the Investigator that he has reviewed and confirmed the information on each eCRF is accurate. This Affidavit text contains something like ‘I, Principal Investigator, for study 9999999, confirm I have reviewed this CRF form….’
Investigator– 21 CFR 50.3(d) defines the investigator as “The individual who actually conducts a clinical investigation – i.e., under whose immediate direction the test article is administered.”
Some recomendations about eSignature can be further research on Secure Access For Everyone (SAFE) standards. The goal is that once the investigator is credentialed by SAFE, his/her identity and electronic signature can be used by all SAFE compliant sponsors.
Training must be provided to sponsors users prior to granting access to an InForm trial. For example, CRAs will need to be well trained on all aspects of the EDC system in order to provide coaching for the investigator. This file documents all sponsors and site staff users within each clinical trial.
Easy, wasn’t it? Again, build your trial and test to make sure all files were cooked and working as expected. Log into your trial and ensure that the special files appear correctly. Enroll a subject to ensure the enrollment confirmation screen appears and, if used in the trial, the visit calculator appears.
Electronic Clinical Data Capture, Position Paper Revision 1, May 1, 2005
Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.