CLINICAL TRIAL ADMINISTRATIVE PROCESS
Clinical Trial Administrative Process
Feasibility/Preparatory Stage
Initial Sponsor Contact with the Research Site
Barlicki University Hospital, Łódź
Pomorska 251, 92-213 Łódź
Contact: Beata Strzelecka
b.strzelecka@csk.umed.pl
phone: 42 675 75 48
University Hospital No. 2
Żeromskiego 113, 90-452 Łódź
Contact: Dorota Prus
d.prus@usk2.lodz.pl; d.prus@skwam.lodz.pl
phone: 42 639 37 77
Uniwersyteckie Centrum Pediatrii im. M. Konopnickiej
ul. Sporna 36/50, 91-738 Łódź
Kontakt: Beata Strzelecka
b.strzelecka@csk.umed.pl
tel.: 42 675 75 48
UMED Clinical Trials Sp. z o.o.
ul. Pomorska 251, budynek A-2, 92-213 Łódź
Kontakt: Anna Krata
a.krata@umed.pl
tel.: 605 786 176
Kontakt ogólny do Działu Badań Komercyjnych w CWBK UMED Łódź:
Dział Badań Komercyjnych CWBK UMED Łódź
E-mail: badania.komercyjne@umed.lodz.pl
Telefon: 42 272 55 52, 605 786 176
Po pozytywnej ocenie wykonalności badania i potwierdzeniu wyboru Ośrodka, Dział Badań Komercyjnych wyznacza osobę do kontaktu ze Sponsorem lub CRO.
Start up stage
Formalizing the Start-Up Payment Agreement
Submission of Required Documentation by the Sponsor/CRO:
1. Contract Proposal and The Attachments
2. Letter of Authorization from Sponsor to CRO to Conduct Negotiations with the Institution
3. Signing Authority for Designated Representatives
4. Proposed Clinical Study Budget: per-patient cost, Investigator/Site split, and procedure catalog (in Polish)
5. List of Equipment to be Supplied for the Study
6. Clinical Trial Protocol and Related Documents, including Polish-language Protocol Synopsis
7. Copy of the Liability Insurance Coverage
8. Confirmation of All Required Approvals: Ethics Committee (KE), Office for Registration of Medicinal Products (URPL), and EudraCT
9. Pharmacy Manual for the Site Pharmacy
10. Lab Manual
For a smooth submission process, please correspond directly with your assigned contact in the CWBK Commercial Trials Unit
Permits and Registrations
- Preparation and submission of documentation to the Ethics Committee and URPL (Office for Registration of Medicinal Products)
- Ensuring trial is listed in required regulatory systems (EudraCT, URPL database).
- Compliance check against legal and ethical requirements
Agreement Negotiations
- Tripartite Agreement Negotiation(Sponsor/Site/Researcher)
- Establishing the financial terms, scope of work, and responsibilities of each party.
- Agreement on data ownership and publication rights for the results
Trial Management and Implementation
- Participant screening and enrolment per the study protocol.
- Management of study logistics: IP handling, shipping, and site pharmacy coordination.
- Ongoing oversight of trial procedures and participant safety monitoring.
- Reporting of adverse events (AE/SAE).
- Providing regulatory and administrative assistance to the Principal Investigator and site staff.
Clinical Trial Completion
- Finalizing patient visits and recruitment
- Archiving of study documentation in accordance the law and previously established requirements.
- Final review of study closure reports and financial close-out
- Source data verification (SDV)