CRC SOP 08b Data receipt, entry and validation V1 Page 1 of 3 THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES

University of Cape Town Standard Operating Procedures Clinical Research Centre

Title Data receipt, entry and validation Number 08b Version 1

Name Title Signature Date Reviewer Authoriser Effective date Review date 1. Purpose To provide instruction to those data management team members delegated responsibility for receiving, tracking and validating derived data during a clinical study.

2. Scope The Clinical Research Centre (CRC) will advise whether this document is mandatory for research where UCT’s Faculty of Health Sciences (FHS) is the named sponsor or where CRC facilities are used (CRC SOP 02). This SOP may, however, also be adapted for use for studies conducted by UCT clinical researchers where UCT is not the sponsor.

3. Templates/forms CRC 08b.1 CRF transmittal form CRC 08b.2 Data clarification form (DCF) CRC 08b.3 Data entry tracking log CRC 08b.4 DCF tracking log

4. Glossary/definitions Clinical Research Centre (CRC) A centre located in UCT’s FHS that provides advice and services to researchers in order to produce high quality clinical research. The CRC may agree to take on the role of sponsor for specific studies should certain criteria be fulfilled.

Essential Documents Documents which individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced (See South African Good Clinical Practice Guideline, Second Edition. 2006. Appendix C).

Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za) 2 Master File Files for each project containing key documents (such as Essential Documents for clinical trials). The Master File is in two parts – a Sponsor File and Investigator Site File (ISF). 5. Responsibilities and procedure 5.1. Paper case record forms (CRFs) 5.1.1. A member of the data management team designated to perform data receipt/entry will receive monitored case record forms (CRFs) accompanied by a CRF transmittal form completed by the clinical team or monitor (CRC 08b.1). The form will be checked against the CRFs, signed and dated, and a copy returned to the person who sent the CRFs, detailing any discrepancies. CRFs will be thereafter be maintained in a secure and private manner by the data management team until archive under the same conditions as other Essential Documents. 5.1.2. The data receiver will perform pre-data entry checks that: the subject/participant identifiers are recorded on each page correctly, visit dates appear suitable (i.e. no impossible dates/are sequential), data are English (if relevant), there are no relevant missing data, and that the CRF has been signed appropriately. 5.1.3. Discrepancies will be reported to a designated member of the team, usually a data manager, who will supervise creation of a data clarification form (DCF, CRC 08b.2). 5.1.4. A copy of the DCF will be sent to the clinical study team for completion, and approval by the investigator, prior to return for data entry; the original will be retained with the data entry team and a copy kept with the CRF. 5.1.5. Once pre-data entry checks are complete, data entry may begin according to the database- specific process. 5.1.6. Subsequent discrepancies noted during data entry by either manual or electronic checks will be addressed by DCF as above. 5.1.7. Pre-entry checks and data entry will be noted in a data entry tracking log (CRC 08b.3) which will be filed in the Master File (MF) with CRF transmittal forms and other related documentation. DCFs will become part of the CRF for each particular participant. 5.1.8. A Data clarification tracking log (CRC 08b.4) will be maintained throughout the study

5.2. Other sources of data 5.2.1. Data coming from sources other than the CRF (e.g. laboratory data) will be managed by documented study-specific processes. 5.2.2. Should participant identifier or visit/field formats be inconsistent, the process in which they are transformed to be suitable for integration will be documented in a file note or equivalent document. 2 CRC SOP 08b Data receipt, entry and validation V1 Page 3 of 3 THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES

5.3. Data validation 5.3.1. A member of the data management team will liaise with data entry clerks and/or sponsor as to the time-points when the database is ready for data validation checks. Study-specific computerised edit checks will be run, with discrepancies addressed by DCF with the clinical team as above. 5.3.2. Should double-data entry not be used, data will be subject to a 100% proof read of pre- determined protocol-specific primary variables, and a random review of other variables, against CRFs. These reviews will be performed by a designated team member not involved in data entry of those fields. The review will be documented by signature/date on print-outs of the data fields. Discrepancies noted during the review will be addressed by DCF. 5.3.3. For electronic CRFs (eCRFs), once all data corrections as a result of DCFs have been completed, a note of the final data entry from the audit trail will be taken, and the eCRFs printed for monitoring if required. 5.3.4. An exception to this data validation process may be considered when data are entered into an interim database (e.g. for preliminary reports).

5.4. Data coding Should data need to be coded prior to analysis (e.g. adverse event data) this will be conducted according to a pre-defined plan as documented in a file note or equivalent document.

6. Document history:

Version No. Date Reviewer Details of changes

Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)