Table 1.

Standard operating policies (SOP), procedures, and recommendations

SOP or recommendationPurposeElements
GovernanceTo 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-identificationTo 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 usersTo 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 authorizationTo 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 searchesTo 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 reportingTo 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 usersTo 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.