SS-307_Posting_Results_and_Adverse_Events_on_Clinicaltrials3.19.10.gov

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					               DANA-FARBER / HARVARD CANCER CENTER
        STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH


TITLE: Posting Results and Adverse Events on clinicaltrials.gov
SOP #: SS-307                                Page: 1 of 2

Applicable Regulations
& Guidelines:                  U.S Public Law 110-85 (FDAAA)

Other References:              SS-301 Registration of Clinical Trials on clinicaltrials.gov,
                               CTEO Tip Sheet: Posting Results and Adverse Events on
                               clinicaltrials.gov

Responsible Personnel:         Principal Investigator, study staff designee, biostatistician


Policy Statement:              Principal Investigators are responsible for ensuring that results
                               and adverse events of applicable clinical trials, for which they
                               are the responsible party, are posted on clinicaltrials.gov within
                               the required time frame.

Background:                    U.S Public Law 110-85 expanded the requirements of clinical
                               trials registration to include the posting of results and adverse
                               events for certain types of trials. Those trials are: Phase II and
                               beyond clinical trials whose investigational agent is an FDA
                               approved/cleared drug, device or biologic. The law requires the
                               posting of basic results within 1 year of the primary completion
                               date. If the investigational agent is seeking FDA approval, then
                               results need to be posted within 30 days after FDA approval is
                               obtained.

Definitions:
                       Applicable clinical trial (for results posting):
                              Phase II and beyond interventional study of an FDA approved
                              drug, device or biologic.

                       Responsible Party:
                              1) The sponsor of the clinical trial (as defined in section
                              50.3 of title 21, Code of Federal Regulations (or any
                              successor regulation); or

                               2) The principal investigator of such clinical trial if so
                               designated by a sponsor, grantee, contractor, or awardee, so long
                               as the principal investigator is responsible for conducting the
                               trial, has access to and control over the data from the clinical
                               trial, has the right to publish the results of the trial, and has the
                               ability to meet all of the requirements under this subsection for
                               the submission of clinical trial information.
TITLE: Posting Results and Adverse Events on clinicaltrials.gov
SOP #: SS-307                                Page: 2 of 2


                          Primary Completion Date:
                                 Date that the final subject was examined or received an
                                 intervention for the purposes of final collection of data for the
                                 primary outcome, whether the clinical trial concluded according
                                 to the pre-specified protocol or was terminated. This means that
                                 participants could still be receiving treatment, in long-term
                                 follow-up or survivorship but the primary outcome has been
                                 achieved and results will need to be posted.

Procedure:

   1) If it is determined that the Overall PI is the responsible party (per definition
      above) of an applicable clinical trial (per definition above), then the primary
      completion date needs to be identified.

   2) With the assistance of the assigned Biostatistician, obtain data needed to enter in
      Basic Results and Adverse Events on www.register.clinicaltrials.gov within one
      year of primary completion date.

   3) Refer to CTEO Tip Sheet “Posting Results and Adverse Events on
      Clinicaltrials.gov” for detailed description of information required.




Original Approval Date: 3/10/10
Revision Dates:
Effective Date: 4/10/10