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Questionnaire
Electronic ENCePP Register of Studies
Introduction
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is an initiative led by the European Medicines Agency (EMA) aiming at bringing together the available expertise and research experience in the fields of pharmacoepidemiology and pharmacovigilance across Europe in a network of excellence, including relevant research centres, University hospitals, owners of healthcare databases and/or electronic registries and existing European networks covering certain rare diseases, therapeutic fields and adverse drug events of interest.
Whilst the focus of ENCePP is on public and not-for-profit organisations, for-profit organisations may also qualify for participation in the Network provided that they perform studies commissioned by third parties and their main focus is pharmacoepidemiology and pharmacovigilance research. All ENCePP studies are included in the ENCePP Register of Studies.
For further information on the network’s objectives and activities please see About Us.
ENCePP Register of Studies
The ENCePP Working Group “Independence and Transparency” was mandated to develop an electronic Register of Studies in the field of pharmacoepidemiology and pharmacovigilance with a focus on post-authorisation studies. As a result, an electronic questionnaire allowing collection of essential information on the study to be included in the Register has been designed – see below.
Registration of the studies in the Register of Studies before the study commences is one of the CoRe requirements for investigators who wish to conduct an “ENCePP study”. To this end, investigators that accept to conduct an ENCePP study commit to a maximum level of transparency with regard to relevant information pertaining to their investigation. This includes publication of study findings regardless of their (positive or negative) results and granting access to relevant information of the study protocol.
Registration of studies in the electronic Register is mandatory only for “ENCePP studies”, voluntary for all other studies.
Please complete the questionnaire ONLINE, if:
· you and/or your organisation are interested and/or actively involved in performing research in the field of pharmacoepidemiology and pharmacovigilance, and
· you would like to include your study data in the present Register of Studies.
Please fill in this electronic form for the purposes of entering your study into the electronic ENCePP Register of studies. By ensuring the information you provide is complete and up to date, the utility of this database will be enhanced.
[* mandatory information; of note it is mandatory to answer ALL labelled questions]
Section 1: Administrative Information1. Study identification
Official title*: / free text
Study title acronym: / free text
Study type*: / [multiple options possible]
/ Active surveillance
/ Observational study
/ Clinical trial / EUDRACT Number, if available: / EUDRACT number
/ Other (please describe): / free text
Brief description of the study: free text, max 1000 characters
Was this study originally requested by a regulator? *
/ Yes / Country of Regulator: / free text
/ No
/ Don’t know
2. Research centres and Investigator details
Coordinating study entity*
Is the coordinating study entity registered in the ENCePP inventory of research centres?*
/ Yes / Name of Centre*: / short name, as entered in the ENCePP database
/ No / Name of Centre*: / Name under which the centre should be displayed (max 50 characters)
Location*: / City, Country
Details of (Primary) lead investigator*
/ If the (Primary) lead investigator of the coordinating entity belongs to a centre already registered with ENCePP, by ticking this box all contact details will be taken from the details held in the database for that centre.
Or specify contact details for (Primary) lead investigator:
Title* / Please selectDrProfessorMrMrsMs
Last name* / Free text
First name* / Free text
Address line 1* / free text
Address line 2 / free text
Address line 3 / free text
City* / free text
Postcode / free text
Country* / free text
Phone number* / Including country code e.g. 44-1273-223355 or 441273223355
Alternative phone number / free text
Fax number / Including country code e.g. 44-1273-223355 or 441273223355
Email address* / free text
Is this study being carried out with the collaboration of a research network?*
/ Yes / Name(s) of Network registered with ENCePP: / Short name, as entered in the ENCePP database
It is possible to list more than one network
Name(s) of other participating network(s): / Name under which the network(s) should be displayed
It is possible to list more than one network
/ No
Other centre(s) where this study is being conducted*
/ Not applicable (single-centre)
/ Multiple centres / How many centres in total are involved in this study? / Numerical value
Name of Centre(s) registered with ENCePP: / Short name, as entered in the ENCePP database
It is possible to list more than one centre
Name(s) of other participating centre(s), Location:
Name under which the centre should be displayed, City, Country
It is possible to list more than one centre
Countries in which this study is being conducted
/ National study / Country: / free text
/ International study / Countries: / free text
3. Study timelines: initial administrative steps, progress reports and final report
Study timeline / Planned / Actual
Date when funding contract was signed* / dd/mm/yyyy / dd/mm/yyyy
Start date of data collection* / dd/mm/yyyy / dd/mm/yyyy
Start date of data analysis / dd/mm/yyyy / dd/mm/yyyy
Date of interim report, if expected / dd/mm/yyyy / dd/mm/yyyy
Date of final study report* / dd/mm/yyyy / dd/mm/yyyy
4. Source of funding:
Please provide estimates of the percentage of funding by source for this study*
/ Pharmaceutical companies / Name(s): / It is possible to list more than one name / approximate % funding: / %
/ Charities / Name(s): / It is possible to list more than one name / approximate % funding: / %
/ Government body / Name(s): / It is possible to list more than one name / approximate % funding: / %
/ Research councils / Name(s): / It is possible to list more than one name / approximate % funding: / %
/ EU funding scheme / Name(s): / It is possible to list more than one name / approximate % funding: / %
/ Other / Name(s): / It is possible to list more than one name / approximate % funding: / %
5. Contact details for enquiries
Scientific Enquiries*
/ Use the same details of (Primary) lead investigator
Or specify other contact details:
Title* / Please selectDrProfessorMrMrsMs
Last name* / Free text
First name* / Free text
Address line 1* / free text
Address line 2 / free text
Address line 3 / free text
City* / free text
Postcode / free text
Country* / free text
Phone number* / Including country code e.g. 44-1273-223355 or 441273223355
Alternative phone number / free text
Fax number / Including country code e.g. 44-1273-223355 or 441273223355
Email address* / free text
Public Enquiries*
/ Use the same details of (Primary) lead investigator
Or specify other contact details:
Title* / Please selectDrProfessorMrMrsMs
Last name* / Free text
First name* / Free text
Address line 1* / free text
Address line 2 / free text
Address line 3 / free text
City* / free text
Postcode / free text
Country* / free text
Phone number* / Including country code e.g. 44-1273-223355 or 441273223355
Alternative phone number / free text
Fax number / Including country code e.g. 44-1273-223355 or 441273223355
Email address* / free text
Section 2: Targets of the study
6. Study drug(s) information
Study drug information*
/ Not applicable (disease epidemiology study)
/ Substance class / ATC code(s)
/ Single drug(s) / Substance INN
/ Multi-constituent / Substance INN(s)
/ Brand Name / Product name, country and substance (INN)
7. Medical conditions to be studied
Medical condition*
/ No particular condition
/ Medical condition(s) specified: / Please use MedDRA LLT term
8. Population under study
Population under study* [Select all that apply]
/ Preterm Newborns
/ Term Newborns (0-27 days)
/ Infants and toddlers (28 days – 23 months)
/ Children (2-11 years)
/ Adolescents (12-17 years)
/ Adults (18-44 years)
/ Adults (45-64 years)
/ Adults (65-74 years)
/ Adults (75 years and older)
Sex* [Select all that apply]
/ Female
/ Male
Other population [Select all that apply]
/ Renal impaired
/ Hepatic impaired
/ Immunocompromised
/ Pregnant women
9. Number of patients
Estimated total number of subjects*: / Numerical value
Additional information: / (e.g. number of patients per treatment group)
10. Source of data
Is this study being carried out with an established data source? *
/ Yes / Name of data source(s) registered with ENCePP: / Short name, as entered in the ENCePP database
It is possible to list more than one network
Name of data source(s) not registered with ENCePP: / Name under which the data source(s) should be displayed and country where the data source is based
It is possible to list up to 5
/ No
Source(s) of data*
/ Prospective patient-based data collection
/ Disease/case registry
/ Prescription event monitoring
/ Administrative database, e.g. claims database
/ Routine primary care electronic patient registry
/ Exposure registry
/ Pharmacy dispensing records
/ Case-control surveillance
/ Spontaneous reporting
/ Other (please describe):free text
Section 3: Methodological aspects
11. Scope of the study
What is the scope of the study? And which is the primary scope? *
[Select all that apply] / Primary scope [select one]
/ Disease epidemiology /
/ Risk assessment /
/ Drug utilisation study /
/ Effectiveness evaluation /
/ Other (please describe): free text /
12. Main objective(s)
Which is the main objective of the study?*
[Free text field, max 400 characters]
Are there primary outcomes?*
/ Yes (please describe): [Free text field, max 400 characters]
/ No
Are there secondary outcomes?*
/ Yes (please describe): [Free text field, max 400 characters]
/ No
13. Study design
/ Sentinel sites
/ Intensive monitoring schemes
/ Prescription event monitoring
/ Cross-sectional study
/ Cohort study
/ Case-control study
/ Case-series
/ Case-crossover
/ Self-controlled case series
/ Drug utilisation study
/ Pharmacokinetic study
/ Pharmacodynamic study
/ Drug interaction study
/ Randomised controlled trial
/ Non-randomised controlled trial
/ Other (please describe): free text
14. Follow-up of patients
Will patients be followed up? *
/ Yes
Please describe duration of follow-up: free text
/ Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method*
e.g. risk estimation, measures of risk, internal/external validity
free text, max 1000 characters
Section 4: ENCePP Seal and relevant documents
16. ENCePP seal
Are you requesting the ENCePP seal for this study?*
/ Yes
/ No
17. Full protocol
Please upload the full protocol* for ENCePP studies
Document [Upload] / Latest version [Upload document]
For ENCePP studies please be aware that the protocol will be made public when the study ends. Would you like to make the protocol public now? * for ENCePP studies
/ Yes
/ No
18. Study results
Please upload a summary of the study results* for ENCePP studies
Document [Upload] / Latest version [Upload document]
Please list the most relevant publications using data from your study * for ENCePP studies [Up to 5]
1. Reference free text / Link to web-publication (if available)
19. Other relevant information
Conflict(s) of interest of investigator(s)* for ENCePP studies
Document [Upload document] / Latest version [Upload document]
Composition of Steering Group and Observers* for ENCePP studies
Document [Upload document] / Latest version [Upload document]
Other documents [Up to 5]
Description / Document [Upload document] / Latest version [Upload document]
Reminder: please make sure you have submitted hard copies of the documents listed below to the ENCePP secretariat so that they can be scanned and uploaded for you.
/ Signed Code of Conduct Checklist* for ENCePP studies
/ Signed Code of Conduct Declaration* for ENCePP studies
/ Signed Methodological Checklist* for ENCePP studies
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Data Entry Form: Electronic ENCePP Register of Studies