Julius Center for Health Sciences
and Primary Care
DB and eCRF development
Type of document
Standard Operating Procedure
Document code
JCDM/PR9002
Current version
1.1, 28-11-2013
previous version
Original date
Scope
Auteur(s)
Reviewer(s)
1.0, 05-02-2014
28-11-2013
Datamanagement , eCRF and database
S.L. Schmikli
J. Schotsman
Validation
Summary of changes
______________________________
Name Procesowner
_______________
Date
__________________________
Signature
______________________________
Name Quality controller
Minor textual
_______________
Date
__________________________
Signature
© Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands. Alle rights preserved.
This document contains confidential information. Transfer of this information to third parties without
written permission of the Julius Center is prohibited. The same applies to to copies of this document
or parts of this document.
Julius Center
CONTENT
1
2
3
4
5
6
7
ABBREVIATIONS AND DEFINITIONS
INTRODUCTION
AIM
LEGISLATION AND STANDARDS
ROLE AND RESPONSIBILITIES
PROCEDURES
REFERENCES
Document1Document1
Confidential. Valid only on the day of printing;23/03/2016
3
3
3
3
4
4
5
2/5
Julius Center
1.




ABBREVIATIONS AND DEFINITIONS
SOP
JC
RO2
JCDM
 eCRF
 GCP
Standard Operating Procedure
Julius Center for Health Sciences and Primary Care, UMC Utrecht
Research Online 2
Data Management of Julius Center for Health Sciences and Primary Care, UMC
Utrecht
Electronic Case Report Form
Good Clinical Practice
2.
INTRODUCTION
At JCDM, eCRF’s are designed using Research Online (RO2). RO2 is a web-based tool to
gather digital clinical research data. It has been developed according to GCP rules
containing monitoring options, full audit trails access control and version tracking of
eCRF’s.
3.
AIM
The aim of this procedure is to define the key processes in designing the eCRf and the
associated database. Details about these processes can be found in specific work
instructions.
4.
LEGISLATION AND STANDARDS
For clinical trials the minimum standards is based on ICH-GCP (http://www.ich.org/)
* Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording and reporting trials that involve the
participation of human subjects.
* Compliance with this standard provides public assurance that the rights, safety and
well-being of trial subjects are protected and that the clinical trial data are credible.
Document1Document1
Confidential. Valid only on the day of printing;23/03/2016
3/5
Julius Center
5.
ROLE AND RESPONSIBILITIES
ROLES
RESPONSIBILITY
Administrator/ Senior Data Manager
(SDM)

approve on the documentation of data structure for a
study/project

approve any amendments or checklist and agree with
timeline of DB development design a system for data
collection

make sure the collected data can be output in the
way it is suitable for analysis

preparation training documentation of data collection
system

Draft necessary documentation

Create studies

Assign Data Managers to a study.

develop a user-friendly data collection system

make sure the collected data can be output to enable
analysis

provide the necessary documents (e.g. protocol,
amendments, etc.) and information needed to
develop a data collection system

timely inform the responsible Data Manager of the
status of the project

approve the final eCRF interface
Researcher/Data entry specialist
(RDE)

perform Data Entry at the research location
End User (EU)

data entry by study participants
Data Manager (DM)
Project Leader or delegated
researcher (PL)
6.
PROCEDURES
6.1 Planning
Before starting DB/eCRF development and design, the SDM analyses what is needed
according to the request from the PL. SDM carries out the following tasks associated to
the intake process (See SOP JCDMPO_PR01 Verwerven en Initiëren Opdracht):
a. Review proposed work and current forms (paper CRF).
b. Collect information on user-requirements, system-requirements, and other
requirements if applicable.
c. Develop a project plan and delegate the work to appropriate personnel, normally a
data manager.
6.2 Design and development
d. Define a study (SDM).
e. Assign data manager(s), if necessary with a new accounts (SDM).
Document1Document1
Confidential. Valid only on the day of printing;23/03/2016
4/5
Julius Center
f.
g.
h.
i.
j.
Draft a data dictionary for documentation of the DB/eCRF structure (DM).
Define data export module (DM).
Design a user-friendly interface for Data entry specialist/ End-user (DM).
Coding of programming need to be applied for technical issue solving (DM).
Use versioning for the DB/eCRF system to ensure everyone is working on the same
platform (DM).
k. Assign Researcher/Data entry specialist(s) and provide rights to add study
participants/end users.
l. General work instructions for design (JCDM WI021) and specific work instructions to
define a study (JCDM WI012), user and site management (JCDM WI016), and to apply
complex rules in the forms (JCDM WI022) are available.
6.3 Testing and validation
Testing and validation will be carried out before the DB/eCRF system is released for LIVE
data entry.
6.4 Implementation and training
If applicable, implementation and training phase will be carried out before the DB/eCRF
system is released for LIVE data entry.
6.5 Maintenance and Evaluation
The DB/eCRF should be continuously monitored by a process to capture user feedback about
the system to identify system errors, missing functionality or increased functionality.
7.
References
a.
Association for Data Management in the Tropics, ADMIT-003-00-SOP-database and eCRF
Design, Version 1.0, 10-JAN-2013
Document1Document1
Confidential. Valid only on the day of printing;23/03/2016
5/5