Datamanagement Plan
Applicable for investigator initiated studies covered by the Medical Research Involving Human Subjects act
NL-number
Title
Short title
DMP version number and date
Coordinating investigator / project
leader
NL-----.091.14
The effect of .......
The effect of ......
Version 1.0
de Gxxxx, Byyyy
van der Fxxxxx, Myyyy
Date:
(last name, first name)
Data Coordinating Center / Data
Management Contact(s)
Type of study
Wxxxx, Eyyy
(last name, first name)
Single centre
Multi centre, number of sites:
Total number of patients (approximately):
Non randomized
Randomized controlled
If randomized controlled:
Open label
Single blind
Double blind
Please indicate that the following applies:
We acknowledge that the handling of the study data is the responsibility of the coordinating
investigator/project leader
This study and all persons involved have knowledge of and comply to the most recent version of:
the Dutch Personal Data Protection Act (De Wet Bescherming Persoonsgegevens, Wbp).
the Code of proper Coduct (Code Goed Gedrag – FEDERA)
Instructions for and more information about the questions below can be found on the CRCN Data
Management intranet pages.
Name Data Management NA (big data)
system used
Castor EDC
Yes
Is this a validated system
No,
if not, provide reason why a non validated system was used Castor is a
Describe the types of
data, the sources and
flow of collection and
storing of data (number
of steps dependent on
validated system. However, mainly big data will be generated (from MRsystem). For this type of data, no validated system is available.
Step Type
Source
System/format
1
e.g.: patient data, life
style items, genetic data,
lab results,....
e.g.: EPIC, paper, lab
system, measuring
device,.....
e.g.: MACRO,
Castor, Excel,
paper, SPSS, .....
MR data
MR system
Dicom
Datamanagement Plan
Applicable for investigator initiated studies covered by the Medical Research Involving Human Subjects act
NL-number
study)
Location of and access
to the study data
1. paper
2. electronic
2
3
4
NL-----.091.14
Lab data
Patient data
patient reported
outcomes
Paper
Paper
questionnaire
(paper)
Castor
Castor
Castor
5
1. If on paper
Location of cabinet: Department of ZZZZ, roomno RRR
Locking of and access to cabinet is GCP compliant
This cabinet is different from the location of the codelist
2.And / If electronic
\\rdscience\mrs_data5 (MR data) and Castor servers Not in My
Documents (folder with z-number)!
(server instance, localization, folder name including (sub)directory)
Method of coding
Location of and access
to the codelist
1. paper
2. electronic
This folder is password protected
The password is kept safe from unauthorised use
At least two persons have access to this folder, name: E.C.
Wiegers and name: drs. H.M.M. Rooijackers
This folder is different from the location of the codelist
The data are coded by the following method: Data will be organized
under anyonymous coding (consecutively assigend study number). The
data will be stored apart from the person's identifying information. Also
identifying information from the header of MR data will be replaced by
this subject number.
1. If on paper
Location of cabinet:
Locking of and access to cabinet is GCP compliant
2. And / If electronic
\\rdxr11\u3 Not in My Documents (folder with z-number)!
(server instance, localization, folder name including (sub)directory
Data back-ups
Software used for
This folder is password protected
The password is kept safe from unauthorised use
At least two persons have access to this folder, name: J.Jxxxxx and
name: S. Syyyy
Yes, frequency: every 24 hours (\\rdscience\mrs_data5) or twice a
day (Castor)
SPSS
SAS
MatLab
Other, specify: Graphpad Prism
Datamanagement Plan
Applicable for investigator initiated studies covered by the Medical Research Involving Human Subjects act
NL-number
analysis
Locking* of data and
codelist
NL-----.091.14
Method of locking data: data is locked in Castor
Method of locking codelist: sealed DVD disk in locked cabinet
* freeze data and codes (file/paper) so they become uneditable
Archiving of data,
codelist and analysis
files **
Location of archiving data: From \\rdscience\mrs_data5 (big data), data
can be restored/archived for 6 months
Location of archiving codelist: sealed DVD disk in locked cabinet
Location of archiving analysis files: DANS
** how and where do you securely store all files/paper, e.g. with DANS,
network folder, sealed DVD disk in locked cabinet, protected paper archive....
This form is filled in by
E. Kyyyyyyyy
Date:
Optional questions
The following optional questions on data quality help to:
 get an idea of current practices and ideas in the UMC,
 help to create and improve policy and guidelines with regard to data quality.
You input is highly appreciated! Additional ideas and suggestions can be mailed to
Ariaan.Siezen@radboudumc.nl.
You can skip the questions below if you have already answered them in a previous plan.
Quality checks
I document all procedures and actions during my studies, so as to facilitate
future replication by a third party (I have well defined SOPs).
If yes, please explain what kind of SOPs and measures you apply:
If not, explain why:
I check my study data on completeness, validity and consistency, by means
of:
manual checks
system checks during data entry
quality reports
other:
If not, explain why:
Please describe your personal definition of data quality:
Would you like more information on this subject? Yes
No
If yes, by means of training/information on CRCN website/other:
Do you think data quality is an important issue? Yes
Please explain:
No
Do you think the Radboud UMC should work at improving data quality?
Yes
No
If yes, what do you think we should do:
Thank you for taking the time to contribute to better research!