11. DATA REPORTING / REGULATORY REQUIREMENTS Adverse event guidelines a nd instructions for AE reporting can be found in Section 6 (Adverse Events: List and Reporting Requirements) . 11.1 Data Management All information will be collected on study- specific case report forms (CRFs) by study staff. These data will be reviewed for completeness and accuracy by the Principal Investigator. 11.2 Safety Meetings Scheduled meetings will take place weekly and will include the protocol principal investigator, study coordinator(s), research nurse (s), and sub-investigators (as appropriate). During these meetings matters related to the following will be discussed: safety of prot ocol participants, validity and integrity of the data, enrollment rate relative to expectation, ch aracteristics of participants, retention of participants, adherence to protocol (poten tial or real protocol violations), data completeness, and progress of data for objectives. Quarterly teleconferences w ill be scheduled to include the Investigator and Merck representatives. During these meetings, the I nvestigator shall provide Merck with study progress updates. The Investigator will provide a summary of key points from the weekly meetings with a focus on safety of th e protocol participants, enrollment status, and progress of data for objectives. In addition, Merck will provide safety and applicable program updates to the Sponsor. 11.3 Monitoring Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 54This is a DSMP Level III study unde r the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC). Data monitoring of this protocol will occur on a regular basis with the fr equency dependent on the rate of subject a ccrual and the progress of the study.