Biogen RDC Kit Reference Guide 102411 - PPDstorage.ppdi.com › edc › clients › BIIBGuides › English › Guides › RDC … · Many Biogen Idec paper studies use log style CRFs

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RDC Roles and Responsibilities RDC has several basic roles that are available to users that enter, update, review and approve data.

• Data Entry • Responds to queries

Site User

• Reviews CRF data • Approves CRF pages • May provide data entry (train as Site User and request these privileges)

Principal Investigator

• Reviews data and source documents • Issues manual queries • Reviews queries (as needed) • Verifies CRF pages

CRA/Site Monitor

• Reviews Data • Issues Queries • Resolves Data Issues and Queries (as needed)

Data Management




RDC Definitions

• A data entry page in RDC is called the CRF. Sometimes referred to as “eCRF” or “page” in RDC CRF

• A collection of CRF pages available for data entry Casebook

• A discrepancy is data that falls outside of an expected range of values • Discrepancies � Queries Discrepancy

• Queries that are generated by the DM or CRA within RDC Manual Queries

• Queries that are generated by RDC as the result of programmed RDC edit checks • These queries can appear when a CRF is saved or after Batch Validation (see Batch Validation) System Queries

• A process that executes all edit checks built into the database to cross-check multiple data fields possibly on multiple case report forms Batch Validation

• Verification in RDC verifies that a CRA has monitored source data and resolved outstanding data issues on a CRF, also referred to as Source Document Verification or SDV Verification

• The electronic equivalent in RDC of the Investigator Signature for a CRF page, and for all the data corrections and queries resolved Approval

• A CRF page saved with data Saved CRF

• A CRF page saved without data using the “Blank Page” tool in RDC Blank CRF




How Biogen Idec RDC differs from Paper Studies Many sites are already familiar with Biogen Idec studies but use paper CRFs instead of RDC. There are some similarities and differences between RDC studies and paper studies! The look! Biogen Idec RDC has CRF pages that look similar to paper CRFs.




Pop-Up CalendarRDC has a pop-up calendar function.




List of Values RDC also has Check box functionality and “drop down” menus that can be used to pick from a list of values for entering data.




Indicator Pages RDC also has separate “Indicator pages” with leading questions that allow sites to enter “YES” to indicate that more information is expected on a corresponding CRF. “N ” can be entered when additional data is not available and the site will not enter any additional data.

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Log Style CRFs Many Biogen Idec paper studies use log style CRFs. These pages usually have line numbers that allow the site and data management to reference a specific entry when providing data revisions or resolving queries. In RDC the line numbers are no longer present.




Date of Visit CRFs RDC studies also include a “Date of Visit” page for all scheduled visits. This page will always be the first page in a visit.




RDC Data Flow

Data entered into RDC

Data reviewed and queries issued by: - System

- Data Management

- CRAs

All data updated and

all queries resolved

RDC data source

document verified by

CRAs

RDC data reviewed and approved by Investigators

“Clean” Trial Data




RDC Expectations – For Data Entry

Do not let data entry accumulate!

• 5 business days

During the study

• 2 business days

Six weeks prior to database lock

• 1 business day

Two weeks prior to database lock

• within 1 business day

Week of database lock




RDC Expectations – For Query Management

Manage queries between monitoring visits!

• 10 business days

During the study

• 2 business days

Six weeks prior to database lock

• 1 business day

Two weeks prior to database lock

• within 1 business day

Week of database lock

Documents

Biogen RDC Kit Reference Guide 102411 - PPDstorage.ppdi.com › edc › clients › BIIBGuides › English › Guides › RDC … · Many Biogen Idec paper studies use log style CRFs