from DF - reinforcing Polkadots statement that the

from DF - reinforcing Polkadots statement that they would not be altering protocol: http://www.dfhcc.harvard.edu/fileadmin/DFHCC_...081709.pdf

It is critical that the protocol document be kept as simple as possible and that only necessary
requirements and tests be included in each trial. Once a protocol is activated, it must be followed as
written (except for emergent safety reasons as described below). All auditors will monitor compliance with
the protocol as it was written and approved. The more complicated a protocol, the more difficult it is to
follow. Consistency and accuracy are critical. Although amendments can correct issues with the protocol,
these require increased effort from the investigator and time for appropriate review. Therefore, careful
consideration of the trial design, including eligibility requirements, required data elements, and length of
follow-up is essential.
Investigators may not improvise on the protocol plan. A protocol must be implemented exactly as it is
approved.
Many protocols include follow-up. It is important that the protocol and the consent identify the information
and procedures that will be included in follow-up of the participant.
Any changes to be made must be first approved by the IRB, unless the safety of research participants
enrolled is at stake.