WIM

Commercial clinical trials – principles of conducting research at WIM-PIB

The establishment of the Clinical Research Support Centre (CWBK) at the Military Institute of Medicine – National Research Institute (WIM-PIB) is a response to the needs of Sponsors and thus improves the quality of administrative services and communication between the Sponsor, the Investigator and the Centre.

Below we have collected key information and documents required at WIM-PIB before and during the implementation of a clinical trial.

General Information

• A proposal to conduct a commercial clinical trial at WIM-PIB should be submitted to CWBK at the following address: badaniakliniczne@wim.mil.pl.
• On behalf of WIM-PIB, the Confidentiality Agreement with the Sponsor/CRO is signed by the CWBK Manager.
• The feasibility study is prepared and submitted to the Sponsor by the Researcher or a CWBK employee within 5 calendar days of receiving the inquiry.

Agreement

• WIM-PIB signs tripartite agreements: Sponsor/CRO-WIM-Principal Investigator. The Sponsor is obligated to provide in paper form:
  • study protocol;
  • a copy of the Sponsor's and Investigator's civil liability insurance policy;
  • a copy of an extract from the National Court Register of the Sponsor and/or CRO or another extract from the register confirming the legal status of the Sponsor and/or CRO;
  • power of attorney of the person signing on behalf of the Sponsor and/or CRO.
• According to internal arrangements, the CWBK standard is 60 calendar days to sign a contract for conducting the study, which requires cooperation from the Sponsor/CRO.
• WIM-PIB collects fixed fees for conducting commercial clinical trials.
  
  

Fixed fees in commercial clinical trials of medicinal products and medical devices

The administrative and legal fee for processing the application for consent to conduct a clinical trial and negotiating the clinical trial agreement (startup fee) is PLN 10000 net plus VAT. Invoice issued by WIM-PIB within 7 days of signing the agreement;

Administrative and legal fee for activities related to the qualification visit and preparation of study documents for submission to the regulatory authority (pre-startup fee) without signing an agreement in the amount of PLN 2000 net plus VAT. Invoice issued by the Institute within 7 days of receiving notification from the Sponsor of withdrawal from conducting the clinical trial;

Administrative and legal fee payable annually starting from the second year of the contract term, in connection with the negotiation of an annex to the clinical trial agreement, in the amount of PLN 2000 net plus VAT. The invoice will be issued by the Institute within 7 days of signing the annex in the second year of the contract term;

The pharmaceutical fee for preparing the pharmacy for the clinical trial, storing the investigational product, and providing pharmaceutical supervision during the first year of the trial is PLN 7000 net plus VAT. The Institute will issue an invoice of PLN 3000 net for storing the investigational product within 7 days of delivery of the investigational product to the hospital pharmacy. The Investigator will divide the amount of PLN 4000 net among the designated pharmacists for pharmaceutical supervision. The fee does not include the pharmacist's remuneration for preparing infusions of investigational medicinal products.

The pharmaceutical fee for storage of the investigational product and pharmacovigilance, starting from the second year of the contract, is PLN 6000 net per year plus VAT. The Institute will issue an invoice of PLN 2000 net for storage of the investigational product with the first payment in each subsequent calendar year. The Investigator will divide the PLN 4000 net amount among the designated pharmacists for pharmacovigilance. The fee does not include the pharmacist's remuneration for preparing infusions of investigational medicinal products.

The fee for disposal of the investigational product/unused investigational product/comparators/premedications/medical waste is PLN 400 net plus VAT for the first participant included in the clinical trial. Invoice issued by the Institute at the end of the clinical trial based on the Waste Transfer Card; If no patient is included in the clinical trial, the Institute will issue an invoice for a lump sum of PLN 500 for disposal of the investigational product/unused investigational product/comparators/premedications/medical waste;

Fee for long-term storage of clinical trial participant biological samples – PLN 2000 net plus VAT for each month of storage. Invoice issued by WIM-PIB after the last sample storage period ends;

Fee for archiving clinical trial documentation (after the trial is completed) in net amounts plus VAT:

Fixed fees in commercial observational, non-interventional, registry studies

The administrative and legal fee for processing the application for consent to conduct a clinical trial and negotiating the clinical trial agreement (startup fee) is PLN 4000 net plus VAT. Invoice issued by the Institute within 7 days of signing the agreement;

An administrative and legal fee payable annually, starting from the second year of the contract, for negotiating an amendment to the clinical trial agreement in the amount of PLN 2000 net plus VAT. An invoice will be issued by the Institute within 7 days of signing the amendment in the second year of the contract;

Fee for archiving study documentation (after completion of the study) in net amounts plus VAT:

Instruments

Equipment provided for the duration of the trial by the Sponsor/CRO or external supplier should be delivered to the Integrated Warehouse at WIM-PIB and recorded in the off-balance sheet. The basis for acceptance of the equipment by the Integrated Warehouse employee (ul. Szaserów 128, 04-141 Warsaw) is the clinical trial agreement signed by the parties and the handover protocol.

Settlement of the study

After each settlement period, as specified in the agreement, the Sponsor/CRO will request an invoice from WIM-PIB via email (ekowal@wim.mil.pl or finanse@wim.mil.pl). Transfers to WIM-PIB's bank account should include the protocol number and the Principal Investigator's name and surname, which facilitates the accounting process.

Documents to download

Clinical Research Support Center

Szaserów Street 128, 04-141 Warsaw

Block E-1, floor 3

 

Patient Contact/Office
Phone: + 48 261 817 013

e-mail: cwbk.rekrutacja@wim.mil.pl

 

Contact for Sponsors

Ewelina Kowal
Phone: + 48 665 707 584

Monika Zdaniecka

tel.: +48261817015

e-mail: researchkliniczne@wim.mil.pl