Table 1.

Standard Operating Policies (SOPs), Procedures and Recommendations.

SOP or Recommendation	Purpose	Elements
Governance	To ensure that all TCRN members participate in governing the network	Defines the role and tasks of the TCRN Executive Committee Defines the role and tasks of the TCRN Policies and Procedures Subcommittee
Validating Quality of De-Identification	To ensure that TCRN members achieve an acceptable level of text de-identification	Defines minimum requirements for validation of de-identification at each member institution during the initial load process and annual ongoing QA Describes required actions for reports with PHI
Verifying Eligibility of Users	To ensure that only eligible investigators from member institutions are granted TCRN access	Defines the criteria TCRN applicants must meet in order to become TCRN users
Study Registration and Authorization	To outline the requirements and procedure for TCRN study registration and authorization	Describes the requirements and procedures TCRN applicants, TIES Administrators, and Approval Committees must follow to authorize TCRN studies
Procedure for Increasing Level of Access to TCRN (Step Up Requests)	To outline the process for users to increase their level of access to the network	Describes the process TIES or TCRN users follow to request higher level access to TCRN
Auditing of Users and Searches	To ensure that all users accessing TCRN are using the network appropriately and assess value of TCRN	Describes three forms of auditing to determine 1) that current users are valid users, 2) that searches are within the scope of the user’s approved use of the system, and 3) the value that the network provides Defines steps to be taken if audit detects an invalid user or high-risk activity
Incident Reporting	To describe incidents that may arise in TCRN and how members must report and respond to them	Provides step-by-step instructions for administrators and regulatory managers of managers of TIES nodes Includes procedures for dealing with eight potential security and privacy threats
Recommendation for Member Institutions on Establishing Approval Bodies for External Users	To suggest a streamlined and consistent process by which external collaborators gain access to institutional data	Provides recommendations for how network sites should establish and run their Approval Committees

^*All current SOPs and Recommendations are available at http://ties.pitt.edu/tcrn