A Data Management Plan (DMP) outlines the management of research data throughout a project's duration and post-completion, emphasizing benefits such as efficiency and compliance with funding requirements. Essential documentation includes study protocols, case report forms, data dictionaries, and study reports to ensure data is accurately recorded and retrievable. The document also details user access procedures and Standard Operating Procedures (SOPs) to maintain data quality in clinical trials.

1. DATA MANAGEMENT PLAN

2. DATA MANAGEMENT PLAN
A DMP is a document that describes how
research data is to be managed both
during a research project and after it has
been completed

3. Why do you need one?
• By planning well you can save time
• Keep track of your data throughout and after your project
• Research project planning will get easier
• Identifying resource requirements
• Easier to identify time dependencies or problems
• When applying for funding, having a DMP will be beneficial
• Make your data FAIR and reusable
• Comply with any funder requirements
• If/when sharing data gives you credit in research assessment schemes

4. DMP documents
• Your data documentation should contain at least the minimum information needed to be able to reuse
the data it is describing. Providing metadata is one of the most common ways provide this information.
• There are different ways to document and describe data. Which method is best will depend on the
project, your team, and the data's complexity. The important part is making sure it is done and done
well.
• The exact details of your documentation method will probably be established after the grant has been
funded but before, or shortly after, data collection has begun.

5. Essential documents
• Study protocol: The study protocol is the blueprint for the study, and provides detailed information on the study design,
objectives, endpoints, and methods for data collection and analysis.
• Case Report Forms (CRFs): CRFs are the primary means of documenting the data collected during a clinical trial. They
should be designed to be user-friendly, and should capture all of the data required by the study protocol.

6. • Data dictionaries: Data dictionaries are reference documents that provide definitions and coding systems for the variables
in the study, including demographic information, medical history, and laboratory values.
• Study reports: Study reports are written summaries of the data collected during the study, including summary statistics,
tables, and figures.

7. Proper documentation is a critical component of clinical data management, as it provides a complete and accurate record of
the study, and ensures that the data collected is accessible, retrievable, and usable for analysis and reporting. The quality and
completeness of the documentation can have a significant impact on the validity and reliability of the study results.

8. User access forms
User Access Criterion
At the early stages of a data sharing initiative, the relevant stakeholders need to
agree and determine the
criteria by which the end user will be given authorised access. Example criteria
include:
• The prospective user is a member of an approved organisation or affiliate
• The prospective user meets the baseline academic qualifications
• The research proposal presented by a prospective user align with the provisions
for data use
• Only specific defined user profiles will have access to specific types of datasets

9. Access Authorisation
In conjunction with the access request process, the relevant stakeholders should establish the application
review and approval process. The data governance plan or equivalent should establish if a specific
individual(s), entity, or committee will be given the responsibility to access the appropriateness of the
potential user based on the details provided during the access request process.
If a significant volume of access requests is anticipated, and an electronic means for access requests is
being utilised . there is the possibility to further streamline the process by
programmatically fast-tracking users to approval stage where the applicant meets the defined user
criterion
is met. Users that do not meet the necessary criterion via the automated process will require a manual
review.

10. • Access Requests
• Contingent to the technologies being utilised and the anticipated volume of users expected to gain access, it is recommended
that the access request process follows one of the following approaches:
• The potential user can access a specific online portal and submit an access request.
• The potential users complete an access request form and submits a scanned copy to a specific e mail address.
• Regardless of the agreed method, it is advisable that the application request form/portal should be designed in a manner which
addresses the access criterion requirements as described in Section 3.6.1. For example,
• the form can be a combination of requester information and a set of questions that the potential user needs to answer prior to
submitting the application for review.

11. Sop’s
• An essential element of conducting a clinical trial is ensuring that the data collected is of the highest quality. Equally
important is that the data management process maintains the quality of the data collected.
• UK CT Regulations Schedule 1, Part 2 (9) stipulates that all clinical information shall be recorded, handled and stored in
such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial
subjects remains protected.
• With the above aim, the SOP describes the data management process including: data collection, data entry, data
verification, data storage and protection and database lock.
• The SOP also describes the use of an Independent Data Monitoring Committee for assessing data during interim analyses
and how such a committee should operate.

12. Whishould use SOP
This SOP should be used by All research staff involved with HUTH-sponsored CTIMPs – Chief/Principal Investigator, co
investigators, research nurses, clinical trial assistants, trial managers, clinical trial co-ordinators,
data managers, administrators etc.
• Clinical trials pharmacy staff – technicians and pharmacists
• All HUTH R&D QA staff who manage the sponsorship of HUTH-sponsored CTIMPs
• Research staff involved with clinical trials sponsored by an external organisation where the
• sponsor has no SOP for data management. HUTH R&D SOPs are defaulted to in this case.
• ICH GCP 5.5 specifies that the Sponsor should utilise appropriately qualified individuals to
• supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the
• statistical analyses and to prepare the trial reports

13. For single-site trials where there is just the one investigator site at HUTH, the Sponsor
normally delegates data management to the Principal Investigator (PI). If the PI delegates data
management to another member of the research team this should be clearly specified on the trial Delegation Log.
For multi-site trials sponsored by HUTH, data management may be undertaken by a
Clinical Trials Unit.

14. Sample and over view

15. Examples of test case

16. References
• NCI/DCP website for Cancer Prevention Agent Development Program: Early Phase Clinical Research
• http://prevention.cancer.gov/programs-resources/programs/phase-0-I-II )
• PIO Instructions and Tools
• http://prevention.cancer.gov/clinicaltrials/management/pio/instructions
• Cancer Data Standards Repository (caDSR) https://cabig.nci.nih.gov/community/concepts/caDSR/
• Cancer Data Standards Repository (caDSR), CDE Browser
• https://cdebrowser.nci.nih.gov/CDEBrowser/
• FDA: CFR – Code of Federal Regulations Title 21
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.62