The contents of this document are based on the opinion from the CDISC Team of Data Science Working Group in JCROA (Japan CRO Association), and not the official opinion of all JCROA member companies. Please contact each CRO and confirm the details of the services.
"Compliant Process & Quality" was drawn up based on GSCPP (Points to Consider for Pharmaceutical Industries and CROs to Build and Maintain Better Collaboration; Good Sponsor-CRO Partnership Practices)*1 by the CDISC Team, and "Prerequisites" and "Prerequisites", "DM-SDTM(EDC)", "DM-SDTM(Paper CRF)" and "Statistical Analysis" were edited by adding CDISC related items (yellow cell) to the GSCPP original checklist.
With the start of e-Data submission for NDA, the number of cases in which the preparation of CDISC standards compliant data is outsourced to CROs has increased. On the other hand, at present there are cases where rework and schedule delays occur sometimes due to differences in the procedures and quality standard of organizations and persons in charge at each company.
To address this situation, CDISC Team of JCROA has written up the points to consider for a smooth operation of CDISC standards related services between Sponsors and CROs, by applying the concept of quality management in GSCPP to CDISC services.
Please use this document before start of work, in order to clarify the final deliverables (services), required quality and delivery date, and use it to establish a process for effectively and efficiently creating final deliverables which meet the required quality.
This sheet focuses on "Clarification of required quality and delivery date" and "Establishment of effective and efficient processes" from the viewpoint of quality management. The sheet can be used in various situations, but please use it especially for consensus building before the conclusion of the contract.
In addition, please refer to column F (Impacts of not executing) and column G (Remarks) which are prepared for describing the reason and intention of the check item setting, although both columns are hidden.
Please refer to the presentation materials of "Points to Consider for Effective and Efficient Quality Management of the Contracted Business on e-Data Submission" which was presented at the workshop for the persons in charge of e-Data submission (morning session II), held on October 8, 2019.http://www.jpma.or.jp/medicine/shinyaku/tiken/symposium/
First of all, please check the conditions of the outsourcing business on the "Prerequisites" sheet, and then discuss the details about overview of the services using "DM-SDTM(EDC)", "DM-SDTM(Paper CRF)" and "Statistical Analysis" sheets.
The contents of CDISC related services (yellow cell) are added in the Attachment 1 of GSCPP which intend to identify the deliverables and to clarify the roles & responsibilities on the services of Data Management and Statistical Analysis. Please use these sheets mainly for confirmation at the time of concluding a contract and/or before starting work.