May 2, 2018
1. What parts of the Clinical Study Report (CSR) will be made available?
FDA will post the study report body, the protocol and amendments, and the statistical analysis plan for each pivotal study.
2. Will the datasets and patient narratives from the CSR be published?
Complete line listings of patient information and full patient adverse event narratives are outside the scope of the pilot and will not be included in the materials posted under the Clinical Data Summary Pilot program. Any limited individual patient data or information included within the summary section (i.e., body) of the Clinical Study Report such as a summary discussion of adverse events or lists of deaths that occurred during a clinical trial will generally not be removed. However, specific types of individual patient data or information, such as death date, will be redacted as necessary to protect personal privacy.
3. Who will redact information from the CSR? Will there be an independent third party doing this work?
No. FDA will redact the information.
4. How will the information be redacted? What is the standard? What types of information will be redacted?
FDA will redact information as we currently do when processing these types of documents in response to Freedom of Information Act (FOIA) requests or when posting an action package. This means that FDA will redact selected portions of the CSRs for trade secrets, confidential commercial information, and personal privacy information.
5. What types of information will be redacted as personal privacy information (PPI)?
In determining the types of information that will or will not be redacted as personal privacy information, CDER has considered recent activities of foreign regulators, a commitment to transparency, as well as other changes that led to the availability of more clinical trial data and information. CDER has also taken into account its statutory and regulatory obligations regarding information disclosure and personal privacy protection. Examples are:
- Patient/subject IDs, as well as any other unique patient identifier (e.g., Social Security number), and patient contact information will be redacted;
- Dates linked to the data or information about a specific individual patient participating in a clinical trial will generally be redacted;
- Clinical trial site geographic location information that is linked to the data or information about a specific individual patient participating in a clinical trial will be redacted to the extent practicable;
- Demographic information, such as sex, age, and race, will generally not be redacted, except in very unusual circumstances;
- Names of sponsor employees, clinical investigators, and data monitoring committee members, will generally not be redacted; names of contractor employees will generally not be redacted if the contract relationship is public;
- Clinical site geographic information (not linked to individual patient data) will generally be disclosed;
- Signatures, including wet signatures, and business contact information will not be redacted when the individual’s name (e.g., name of a sponsor’s employee) is otherwise disclosable.
6. Can the sponsor applicant review the redactions before the CSR is posted?
No. As is our practice with action packages and FOIA requests, the sponsor will not have an opportunity to review our redactions before the CSR is posted. If the sponsor is uncertain about whether we will redact certain types of information, the sponsor should ask us in advance.
7. What should I do if I have more questions?
For inquiries about the Pilot, please contact CDER’s Office of New Drugs at ClinicalSummaryPilot@fda.hhs.gov