Standard Operating Procedures

All clinical studies supported by the Clinical Research Office are conducted according to the FDA, HHS, International Conference on Harmonization (ICH) / WHO Good Clinical Practice standards, the Institutional Review Board of Records, regulatory authorities’ requirements, and these Standard Operating Procedures (SOPs). All members of the research team are required to follow and adhere to these SOPs. Each SOP describes a procedure or process carried out in the management of a study or general administration and in the education of clinical trials.

The SOPs are reviewed at a minimum of a biennial basis in accordance with SOP1.1 Preparing, Maintaining and Training Staff on SOPs. If a new process is identified a new SOP is developed at that time and approved by the CRO Management Team. Relevant Research Team Members are notified and required to review the SOP.

All new employees are required to review all SOPs upon hire and provide documentation of review to manager who will include as part of Orientation Checklist (SOP1.3 Orienting Employees and Ongoing Training).

If you have questions regarding any SOP please see your supervisor.

2017 SOP Directory/Index  •  Glossary • CRO Phone Directory

Clinical Research Office Standard Operating Procedures
No. GENERAL ADMINISTRATION OWNER DATE
1.1 Preparing, Maintaining and Training on SOP’s UNM CCC CRO Director /
NMCCA Exec Director
12.14.17
1.2 Responsibilities of the Research Team UNM CCC CRO Director 12.20.17
1.3 Training and Education UNM CCC CRO Director 12.20.17
1.4 Conflicts of Interest in Research NMCCA CRM 3.19.18
1.5 Investigator and Investigative Site Requirements NMCCA Exec Director 3.19.18
1.6 Cooperative Group Participation NMCCA Exec Director 3.19.18
1.7 NMCCA New Study Process NMCCA Exec Director 3.19.18
 No. STUDY START UP  OWNER  DATE
2.1 Assessing Protocol Feasibility NMCCA CRM 3.19.18
2.2 PreStudy Site Visit (PSSV) NMCCA CRM 3.19.18
2.3 Site Initiation Meetings and Visits NMCCA CRS 12.19.17
2.4 Study Activation NMCCA CRS 12.19.17
2.5 Completing an FDA Form 1572 NMCCA CRS 12.19.17
2.6 Submitting a New Study Application to IRB NMCCA CRS 12.19.17
2.7 Federally Required Website Registration Assistant Director of Quality Assurance, Monitoring, and Training 3.19.18
2.8 Protocol Review and Monitoring Committee NMCCA CRM 3.19.18
2.9 Investigator Initiated Study Management Assistant Director of Quality Assurance, Monitoring, and Training 3.28.18
 No. PROJECT MANAGEMENT  OWNER  DATE
3.1 Interactions with Institutional Review Boards NMCCA CRS 12.19.17
3.2 Clinical Subject Records NMCCA CRM 12.18.17
3.3 Monitoring Visits UNM CCC Clinical Operations Manager, NMCCA CRM 3.28.18
3.4 Study Termination (Close Out) Visit NMCCA CRS & UNM CRS 3.19.18
3.5 Investigational Drug Accountability, Storage, Dispensing and Return Research Pharmacist 3.22.18
3.6 Handling of Amendments and Revisions NMCCA CRS 11.14.17
3.7 Electronic Correspondence with the HRPO and GCRC NMCCA CRS 12.21.17
3.8 Long Term Storage NMCCA CRM 3.19.18
3.9 External Adverse Events NMCCA CRS 3.19.18
 No. SUBJECT MANAGEMENT  OWNER  DATE
4.1 Informed Consent – Development and Implementation NMCCA CRS 11.14.17
4.2 Subject Recruitment and Eligibility NMCCA CRM 12.18.19
4.3 Subject Management While on Study NMCCA CRM 12.18.17
4.4 Adverse Event Reporting Assistant Director of Quality Assurance, Monitoring, and Training 12.20.17
4.5 Specimen Collection, Handling and Disposal UNM CCC Clinical Research Operations Manager 3.28.18
4.6 ARCHIVED
4.7 OPEN
4.8 Protocol Deviation Reporting and Prevention NMCCA CRM 12.18.17
4.9 Emergency Use of An Unapproved Investigational Drug or Agent NMCCA Medical Director 3.28.18
 No. DATA MANAGEMENT  OWNER  DATE
5.1 Evelos Disaster Plan Velos Database Manager 3.19.18
5.2 Evelos Accounts and Passwords Velos Data Manager 3.19.18
5.3 Evelos Case Report Form Development and Completion Monitoring UNM CCC Clinical Research Operations Manager 12.19.17
 No. QUALITY ASSURANCE  OWNER  DATE
6.1 Quality Assurance Program Assistant Director of Quality Assurance, Monitoring, and Training 12.20.17
6.2 Internal Audit National Clinical Network Group Clinical Trials Assistant Director of Quality Assurance, Monitoring, and Training 12.20.17
6.3 NCTN Triennial Group Audits Assistant Director of Quality Assurance, Monitoring, and Training 12.20.17
6.4 Preparing for an FDA Audit Assistant Director of Quality Assurance, Monitoring, and Training 12.20.17
6.5 Assuring Subject Safety - Investigator Initiated Trials Assistant Director of Quality Assurance, Monitoring, and Training 12.20.17
6.6 Making a Hand Written Error Correction Quality Assurance Manager 3.19.18
 No. BUDGET MANAGEMENT  OWNER  DATE
7.1 Research Patient Billing Procedures Program Manager, CRO Billing 3.19.18