Should SEND be listed in the Protocol or treated only as a contract deliverable?
We recommend SEND be listed in the Protocol.
Protocols and Reports: SEND datasets are a standardized format of the individual data listings (e.g. report appendix) included in a .pdf final study report submission. SEND datasets may in practice be used for study reviews. Therefore, SEND datasets can generally be referenced in a similar manner to any references to individual listings in the protocol and/or report and subjected to similar QA and QC controls that have been applied to the production of individual data listings.
Pharma companies and CROs may have different approaches to including references to the production of SEND data sets in study protocol. CROs, because they tend to use the study protocol to drive all things which will be done as part of the study commitment to the sponsor, may describe SEND datasets as part of the protocol required study deliverables, when relevant. Pharma companies, may consider the generation of SEND data sets as part of the study reporting process, and therefore could document the requirement in standard operating procedure and/or document the delivery of the SEND datasets in the study report, similar to individual listing generation, as mentioned above. To document clear understanding of the study deliverables, and the associated study set-up and resourcing needs, we recommend listing SEND datasets as part of the planned deliverables within the protocol.
If the decision to create SEND datasets is made after report finalization, a memo to file may be prepared for inclusion with the study data documenting SEND datasets were prepared and a description of the review status (QA, QC, etc.).
Computer systems used for the conduct and reporting of studies are often included in protocols and/or reports. SEND related systems should also be included.
Contracts: For outsourced studies, it will be necessary for the Sponsor and CRO to agree on the expected deliverables of the studies. SEND datasets may not be required of all outsourced study types. If SEND datasets are required, it will have an associated resource impact and may have an associated cost. To assure full agreement on study deliverables and costs, consider inclusion of SEND datasets within the study contract, or statement of work, as applicable.
Last revision by William.houser,09/21/2012