Preliminary Identification Form
SHARING CLINICAL TRIAL DATA WITH QUALIFIED RESEARCHERS
Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR of Chiesi Farmaceutici S.p.A.-sponsored interventional clinical trials in patients for medicines and indications approved by EMA and/or FDA after 1st January 2015.
Chiesi provides access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.
Fundamental conditions for providing the requested clinical trial data are that qualified Researchers agree to sign a Data Sharing Agreement, to use the data only for non-commercial purposes and to seek publication of their research results.
Nevertheless, the access to clinical trial data is not be granted if any of the following apply:
- There is a reasonable likelihood that individual patients could be re-identified: for example, clinical trials of rare diseases, single-centre clinical trials, or clinical trials with a very small number of subjects (< 50 subjects);
- The external research has the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling;
- There are substantial practical and/or technical constraints to provide data access;
- There are contractual or legal or patients’ informed consent provisions that prohibit the transfer of clinical trial data to third parties;
- There is a potential conflict of interest or an actual or potential competitive risk;
- Lack of necessary documentation related to the request.