Establishing registries

The University of Pécs Centre for Translational Medicine (UP CTM) wishes to provide all its partners, clinicians and basic researchers, the opportunity to establish registries.

I. General introduction


As a part of our service, we help and support to start new registries. This includes:

statistical background

IT development

data management and data monitoring

establishing patient clubs

obtaining ethical licenses in Hungary

assisting international distribution

data processing

research and publication assistance

guarantee anonymity and data protection legislation contained in the ethics license

confidentiality

only the data uploaders and approvers from the given institution can acces the data, this other researchers cannot see.

the data uploaders and the approvers can see only their own data, although everyone can see the total number of patients in the registry

If someone has a research idea, she/he has to hand in a research plan to a relevant study group in the TM. The centers can decide if they would like to attend the research.

When establishing registries and launching trials, it is important that everyone should follow the chronological, ethical and monitoring steps that ensure proper operation and full compliance with both confidentiality and copyright rules.


II. Abbreviatons, description, explanation, contact details


PI

Principal investigator

 

SD

Strategic director

p.hegyi@tm-centre.org

OD

Operative director

a.szentesi@tm-centre.org

PRC

Patient registry coordinator

registries@tm-centre.org

IT

IT

it@tm-centre.org

BIOS

Biostatistician

biostatistics@tm-centre.org

DMGD

Data management group director

datamanagement@tm-centre.org

EM

Ethical manager

ethics@tm-centre.org


PI-Principal investigator (given head of registry): The 'engine' of creating and maintaining a registry. 

SD-Strategic director : Making decisions to start a registry.

OD- Operativ director: Supporting the preparation of decisions, assisting in planning the registry, communicaton.

IT-IT Group leader: Creating, testing the online surface and interacting with the IT development team.

BIOS-Biostatistician group leader: Creating a database from the registry, systematizing the data, preparing statistical analyzes, and keeping in contact.

DMGD-Data management group director: Describing the registry to clinical research administrators. distributing tasks, communication, check inbound data. 

EM-Ethical manager: Know the process of ethical licensing, obtaining, forwarding the documentation required for the permit to the relevant authorities and keeping in contact. 


III. Tasks of patient registry coordinator PRC (registries@tm-centre.org)


Coordinate the tasks required for the professional implementation of the project and support the work of the professional leader

Coordinate the tasks/work between the professional attendants of the project 

Efficiently and independently plans time, meets deadlines, initiates and follows through on tasks to ensure that goals and objectives specified for various programs are accomplished

Coordinate the preparation of the professional and technical specifications on time and licensing the documentation related to project implementation.

Preparation of professional consultations and discussions, assembling the documentation and providing information about the achievment of the results. 


IV. Schedule for new registries


1. Determining the purpose of the registry, decision to start a registry. 

The most important questions are:

1.1 Is the registry the most adequate way to achieve the aim?

1.2 Is the registry achievable? (financial and human resources)

1.3 Is this an acute or chronic registry?

PI+SD+OD+PRC

Result: decision about the registry


2. The work starts with the principal investigator, collect the international registry questionnaires, set up the new registry’s questionnaire and one short (approximately one page) summary about the aims (in English).

PI+PRC

Result:summary and questionnaire in English

3. Overview the completed questionnaire with different professional fields

PI+PRC+IT+BIOS+DMGD

Result: decision about the questionnaire


4. The final approval of the registry within CTM.

PI+SD+PRC

Result: Approve the registry


5. The Principal Investigator collates the registry with Hungarian and/or international collegues. If there would be a major change then we should go back to point 4.

PI

Result: consensus


6. Translate the complete documentation into Hungarian, finalize the documents

PI

Result: documentation in Hungarian


7. Parallel work:

7.1 PRC sends to ethical manager the whole documentation, who collaborates with the Principal Investigator in ethical licensing

EM+PI PRC does not have to be involved in the conciliation (!)

Result: TUKEB licence

7.2 IT launches the development. If there is a question IT group leader should contact the PI.

IT+PI PRC does not have to be involved in the conciliation (!)

Result: eCRF

7.3 PI prepares detailed user guide in Hungarian and in English, DMGD and PRC supervise

PI+DMGD+PRC 

Result: User guide (user manual)


8. Testing the electronic case report form (eCRF)

PI+IT+PRC

Result: Finished eCRF


9. With the user guide a detailed local education should be provided to data managers  

PI+DMGD+PRC 

Result: Qualified data uploaders


10. Organize patients involvement locally

PI+DMGD 


11. Involve national and international centers and start the education of them.

PI+DMGD+PRC


12. Follow up and control quality of the registry monthly

DMGD+PRC 

        Data upload has a four part quality check

1. check mark: Data upload by the administrator

2. check mark: Local medical supervision and approval

3. check mark: Approval by leading clinical research administrator, verification

4. cehck mark: Approval and verification by Registry leader/Principal Investigator


13. Data analysis, research and publication   

SD+PI+BIOS+IT+PRC                                                   



V. Collecting data


  • In general, with one center, small-scale registries it is best to collect data in excel, while with multicentre, large-scale registries, it can be reasonable to create a separate, electronic surface (eCRF-electronic case report form).

The collected data belongs to the patient, he/she has disposal of it. By signing the patient consent, the patient agrees that his or her data may be used by the         researcher.

Each researcher/clinician participating in the trial can only access the data of his or her own patient. It is possible to search the complete database, for this a work         plan must be submitted to that workgroup, which after careful examination will be accepted. Other researchers may agree the use of the data they collect. Data         collected by researchers agreed to participate, can be used for analysis without personal patient data.



VI. Publication rules


Complete transparency.

Researchers define the first and the last author, although UP CTM-beside complete transparency- can name co-authors, who worked on the succes of the registry.

In favor of transparent publishing rules, the principal investigator should pre-determine the number of cases to be eligible to co-author. The principal investigator         should take into consideration the given disease and how many cases can be collected.

Acknowledgments should include the sponsors nominated by the UP CTM.


VII. Principal investigator obligations


Anyone who start a registry, must keep it under constant professional control, must take part in the approval of the forms, preferably close the forms as soon as possible (within one month). After an adequate sample size a publication should be made. The principal investigator should regularly participate in discussions at the Multidisciplinary Research Group (at least twice a year), where you can report on results and problems.


UP CTM should represent the uploaders interests as well as the registry starters. The UP CTM is entitled to replace the principal investigator who does not perform his duties and replace it with a new researcher in agreement with the uploading centers. 


Adjudication of changes: Of course, there may be changes here, either in the protocol or in the questionnaire, etc. The Strategic Director (Peter Hegyi) can help make the decision in this situation whether an ethical notification about the modification is necessary. 



49011

Patients

2842

Samples

27

Countries

102

Centers

175

Doctors

14

Registries

11

Trials

sponsors