Standard operating procedure
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1 Standard operating procedure Title: Handling of external requests on EU-CTR and EudraCT Status: PUBLIC Document no.: SOP/INSP/2044 Lead author Approver Effective date: 04-SEP-12 Name: Raffaella Chersoni Name: Fergus Sweeney Review date: 04-SEP-15 Signature: ON FILE Signature: ON FILE Supersedes: N/A Date: 03-SEP-12 Date: 04-SEP-12 TrackWise record no.: Purpose The purpose of this SOP is to define the procedure for the handling of requests related to the EudraCT database and EU Clinical Trials Register (EU-CTR) received from external users (e.g. from journalists, healthcare professionals, patients, the general public ). The EU-CTR contains information on interventional clinical trials on medicinal products. The information available dates from 1 May 2004 when national medicine regulatory authorities began populating the EudraCT database, the application that is used by national medicine regulatory authorities to enter clinical trial data. The EU-CTR website launched on 22 March 2011 enables users to search for information which has been included in the EudraCT database. Users are able to view: the description of a phase II-IV adult clinical trial where the investigator sites are in the European Union (EU) member states and the European Economic Area (EEA); the description of any paediatric clinical trial with investigator sites in the EU and any trials which form part of a Paediatric Investigation Plan (PIP) including those where the investigator sites are outside the EU/EEA. EudraCT is a database of all clinical trials commencing in the Community from 1 May 2004, or third country clinical trials that form part of a Paediatric Investigation Plan (PIP). The database has been established in accordance with Directive 2001/20/EC. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0) Facsimile +44 (0) info@ema.europa.eu Website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 2. Scope This SOP applies to: D-CM (Press Office), P-MI-PIN, V-PD-DIS, P-PV, P-CI-CNC, I-UA-RTS and I-UA- APP. 3. Responsibilities It is the responsibility of each Head of Sector/Section Head to ensure that this procedure is adhered to within their own sector/section. The responsibility for the execution of a particular part of this procedure is identified in the right-hand column of section Changes since last revision New SOP. 5. Documents needed for this SOP N/A. 6. Related documents SOP/EMA/0019 Handling of requests for Information. SOP/H/3386 Handling of external requests for access to information from healthcare professionals, patients and the general public. WIN/H/3320 Documentation of external requests for access to information and their responses from healthcare professionals, patients and the general public. 7. Definitions EudraCT/EU-CTR co-ordinator: D-CM: EU-CTR: EudraCT: EVMPD: I-UA-APP: EMA staff member who manages EudraCT/EU-CTR queries. Communications Sector, Directorate. European Clinical Trials Register. European Electronic Database of Clinical Trials. EudraVigilance Medicinal Products Dictionary. Application Support Section, ICT User and Application Support Sector, Information and Communications Technology Unit. SOP/INSP/2044, 04-SEP-12 Page 2/6
3 I-UA-RTS: P-CI CNC: P-MI-PIN: P-PV: SUSAR: V-PD-DIS: User Registration, Training and Service Desk Section, ICT User and Application Support Sector, Information and Communications Technology Unit. Clinical and n-clinical compliance Section, Compliance and Inspection Sector, Patient Health Protection Unit. Public Information and Stakeholder Networking Section, Medical Information Sector, Patient Health Protection Unit. Pharmacovigilance and Risk Management Sector, Patient Health Protection Unit. Suspected Unexpected Serious Adverse Reactions. Document and Information Services Section, Product Data Management Sector, Veterinary Medicines and Product Data Management Unit. SOP/INSP/2044, 04-SEP-12 Page 3/6
4 8. Process map(s)/ flow chart(s) START 1. Query received via 1.1 Request enquirer to send the query in written format 2. assigns call ID number 3. Is query within scope of? 4. Forward query to EudraCT Technical Support 5. Is query within scope of EudraCT Technical Support? 5.1 EudraCT Technical Support resolves issue and informs 6. Forward query to EudraCT/ EU-CTR co-ordinator 7. Is query within scope of EudraCT/EU-CTR coordinator? 7.1 EudraCT/EU-CTR coordinator drafts and sends reply to 8. Forward query to appropriate team copying in CC 9. Appropriate team drafts and sends reply to IT Service Desk 10. replies and closes call END SOP/INSP/2044, 04-SEP-12 Page 4/6
5 9. Procedure Step Action Responsibility Start 1. Receive query on EudraCT/EUCTR from external user. Is query received via / If yes, go to step 2. If no (query received by P-CI-CNC via phone call), go to step Request enquirer to send the query in written format to the relevant address or 2. Acknowledge receipt of request and assign call ID number through the InfraEudra system st Line Is query within scope of? P-CI-CNC If yes, go to step 10. If no, go to step Forward query to EudraCT Technical Support nd Line EudraCT Technical Is query within scope of EudraCT Technical Support? Support If yes, go to step 5.1. If no, go to step Resolve technical issue and inform by . Then EudraCT Technical go to step 9. Support 6. Forward query to EudraCT/EU-CTR co-ordinator. EudraCT Technical Support 7. 3 rd Line EudraCT/EU-CTR Is query within scope of EudraCT/EU-CTR co-ordinator? co-ordinator EudraCT/EU-CTR co-ordinator EudraCT/EU-CTR co-ordinator 9. Draft reply and send it to via eudract@ema.europa.eu keeping the original call number in the s subject and copying Info@ in CC. 10. Send reply to external user and close call using the InfraEudra system. If yes, go to step 7.1. If no, go to step Draft reply and send it to via eudract@ema.europa.eu keeping the original call number in the s subject. Then go to step Forward query to appropriate team/section/sector (D-CM/P-MI- PIN/P-PV/V-PD-DIS) copying Info@ in CC D-CM/P-MI-PIN/P- PV/V-PD-DIS SOP/INSP/2044, 04-SEP-12 Page 5/6
6 Step Action Responsibility End 10. Records Electronic copies of the requests and their responses are kept by in the InfraEudra system. SOP/INSP/2044, 04-SEP-12 Page 6/6
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