Page 129 - pfizervax
P. 129

PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
                   Protocol C4591001


                   Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used
                   to identify individual participants have been removed) on www.pfizer.com for
                   Pfizer-sponsored interventional studies at the same time the corresponding study results are
                   posted to www.clinicaltrials.gov.

                   Documents within marketing authorization packages/submissions

                   Pfizer complies with the European Union Policy 0070, the proactive publication of clinical
                   data to the EMA website.  Clinical data, under Phase 1 of this policy, includes clinical
                   overviews, clinical summaries, CSRs, and appendices containing the protocol and protocol
                   amendments, sample CRFs, and statistical methods.  Clinical data, under Phase 2 of this
                   policy, includes the publishing of individual participant data.  Policy 0070 applies to new
                   marketing authorization applications submitted via the centralized procedure since
                   01 January 2015 and applications for line extensions and for new indications submitted via
                   the centralized procedure since 01 July 2015.

                   Data Sharing


                   Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes
                   of “bona-fide scientific research” that contributes to the scientific understanding of the
                   disease, target, or compound class.  Pfizer will make available data from these trials
                   24 months after study completion.  Patient-level data will be anonymized in accordance with
                   applicable privacy laws and regulations.  CSRs will have personally identifiable information
                   redacted.

                   Data requests are considered from qualified researchers with the appropriate competencies to
                   perform the proposed analyses.  Research teams must include a biostatistician.  Data will not
                   be provided to applicants with significant conflicts of interest, including individuals
                   requesting access for commercial/competitive or legal purposes.

                   10.1.5. Data Quality Assurance
                   All participant data relating to the study will be recorded on printed or electronic CRF unless
                   transmitted to the sponsor or designee electronically (eg, laboratory data).  The investigator is
                   responsible for verifying that data entries are accurate and correct by physically or
                   electronically signing the CRF.


                   The investigator must maintain accurate documentation (source data) that supports the
                   information entered in the CRF.

                   The investigator must ensure that the CRFs are securely stored at the study site in encrypted
                   electronic and/or paper form and are password protected or secured in a locked room to
                   prevent access by unauthorized third parties.

                   The investigator must permit study-related monitoring, audits, IRB/EC review, and
                   regulatory agency inspections and provide direct access to source data documents.  This
                   verification may also occur after study completion.  It is important that the investigator(s)




                                                            Page 119
   124   125   126   127   128   129   130   131   132   133   134