www.crc.gov.my

1. www.crc.gov.my

2. National Transplant Registry Methodology Dr Jamaiyah Haniff Head, Disease & Treatment Registry Unit

3. Methodology • Background • Components • Organisation • Operations

4. Background • Oct 2003…. NTR 1st sponsor meeting …. appointed CRC as designated collaborating unit • 3 rd Nov 2003….. CRC established …. Transplant Registry Unit (TRU) under the Disease & Treatment Registry Unit (DTRU)

5. CRC in NIH CARTA ORGANISASI RANGKAIAN PUSAT PENYELIDIKAN KLINIKAL INSTITUT KESIHATAN KEBANGSAAN (NATIONAL INSTITUTES OF HEALTH) MALAYSIA Institut Kesihatan Kebangsaan Rangkaian Institut Kesihatan Umum (IKU) Institut Penyelidikan Perubatan (IMR) Institut Pengurusan Kesihatan (IHM) Rangkaian Pusat Penyelidikan Klinikal (CRC) Institut Penyelidikan Sistem Kesihatan (IHSR) Institut Promosi Kesihatan (IHP) CRC Hospital Ipoh Perak CRC Hospital Pulau Pinang CRC Hospital Sultanah Aminah JB CRC Hospital Kota Bharu Kelantan CRC Hospital Kuching Sarawak CRC Hospital Kuantan Pahang

6. TRU in DTRU • Renal Registry Unit • Cancer Registry Unit • Cataract Surgery Registry Unit • Neonatal Registry Unit • Mental Health Registry Unit • HIV/AIDS Treatment Registry Unit • Transplant Registry Unit

14. “DATA IN, REPORT OUT” DTRU Mission statement • The DTRU aims to serve as the national centre for key diseases and treatment registration in the country by providing a range of services starting “from concept to operations” of these registries and through ensuring high quality standards right “from data to report” which would be used to finally effect patients’ outcomeimprovement programmes.

15. Objectives of the TRU in CRC To achieve the objectives of the NTR, the tasks of the TRU are to ensure: • The complete ascertainment of all new cases of transplant performed by all the SDP • The validity of the data collected on these cases of transplant • Timely data capturing and analysing and timely reporting

16. Components of a registry unit INPUT OUTPUT TRU REPORT Manpower Physical Facilities & Hardware Software Work Process Data 

17. Manpower • Clinical Registry Manager (CRM) • Clinical Registry Coordinator (CRC) • Clinical Registry Assistant (CRA) • Epidemiologist • Biostatistician • Report editor • Desktop publisher • Webmaster • Clinical Data Manager • Database Administrator • Programmer • Network administrator • Security officer • Regulatory / Compliance officer

18. Physical Facilities & Hardware • Office space • IT infra: Server, VPN , network, workstation, etc • Communication infra - direct lines, broad band • Archive • Security infrastructure

19. Office

20. Security measures (1)

21. Security measures (2)

22. Security measure (3) – Fire safety facilities

23. Office space

24. On-site Server

25. Archive Facilities

26. Software • Database management • Business administration • Record linkage • Auto encoding

28. Contact / Hospital Management

29. SDP Identification / Enlistment If response is not received from the identified prospective SDP, data manager will try other means to enlist site. If response is received from the Identified prospective SDP, register the SDP as participant. Click Exit to Save this SDP record Click on Add New button to enlist a new SDP. Identified a new SDP: Department of Pathology, Hospital Ipoh To add a contact (SDP / Donor / EPM / Sponsor / etc), click on Contacts. The SDP has been enlisted into the NCR. Send an ‘Invitation to Participate Letter” to this SDP. Tick Confirm SDP as ‘Yes’ to register the SDP as participant. The SDP will appear in SDP Evaluation list Select the SDP as ‘Yes’ for Prospective SDP

30. Monthly Data Submission Tracking and Data Entry Module

31. Data Submission Tracking Click Exit to save Type the date data was received An acknowledgement of data submission letter will appear. This letter is printed out and sent to the SDP. The letter will be printed out and sent to the SDP When the letter is sent, the date will be recorded within the system Data manager will also review the number of data returns (# of patient records) to date. Select ‘Yes’ for the month when data is received At the end of each month, this report will be reviewed by Data Manager to identify the progress of data submission At the beginning of each month, data manager will identify who are the SDPs that have not submitted their data Click this to log a monthly submission by SDP Click on the SDP link and a popup to log monthly data submission will appear

32. Data Review and Coding Module

33. Data Review and Coding After data has been received from EPM, data will be entered into the system. Here, CRC’s medical offier will verify the codes that has been autocoded by the system. They may select one of the following Options: (1) Verified (2)Recode to another major site code (3)Uncertain (4)Query data During de-duplication, patients with duplicate Records will be identified. 1.      To assure the data quality in the database, there should be no duplicate of record For records that were not autocoded by the system, the reviewer will code specimen/HPE based on their judgement The data will be printed out and sent to Expert Panel Members for verification, review and coding. In the meantime while waiting for data to be reviewed by EPM, data Manager will resolve queries arising from patient data. Upon clicking this button, the system will automatically code the specimen and HPE data to ICD-10 Major site code based on a pre-defined keyword dictionary.

34. Work process

35. 1) SDP Identification, recruitment and initiation • Definition of SDP: Treating physicians or surgeons who manage cases of transplant (organ and tissue) • TRU would identify and enlist all SDP • TRU would ensure continuous flow of data by continuing motivation: • KOL, peer and Professional society • Meaningful involvement: Governance Board, Expert panel, NTR supported Transplant Research group • Timely feedback and report • Marketing: web, NTR events etc

36. 2) Data reporting by SDP & Tracking submission 1. Case definition: • All new cases of transplant (lung, heart, heart and lung, liver, cornea, bone marrow, tissue, bone) performed in current calendar year irrespective of type of facility MOH or non MOH, govt or non-govt, local or abroad irrespective of age or nationality • Principle : Liberal: When in doubt, report 2. Types of reporting i. Minimal Data set: Common data ii.Organ Specific form iii. Annual Census and Centre Survey

37. 2) Data reporting by SDP & Tracking submission 2) Data reporting by SDP & Tracking submission 3. Frequency of submission For i and ii minimally monthly submission is requested otherwise if not possible ad hoc reporting. For iii. Annual at year end 4.Methods of reporting: -electronic data capture -paper based

38. 3. Data management (steps 4-10) 1. Visual review for error 2. Login into an automated data tracking system (prompt and reminders) 3. Data entry / verification & updates 4. Run edit checks for non-allowed codes, extreme values, inconsistent data etc 5. Data review and coding 6. Search for duplicate records 7. Periodic intensive Active case finding and site monitoring to round up all the unreported cases & late notifications and other Data Query (need for Direct access to source data and SDP cooperation) 8. Database lock

39. Conclusion • The challenge ……..to commence data collection from 1.1.2004 • The deliverable …….. 1 st first National Transplant Registry Report by July 2005

40. Thank you www.crc.gov.my