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.

2013 SOP Directory/Index  •  Glossary

Legend for the last column — Who Needs to Review:

ALL = CRO, NMMCA Staff, Alliance Sites
AS = Alliance Sites
Lab = Research Lab Staff
Mgr = Supervisors & Managers
NMCCA = NMCCA staff
POD = Nurses, Research Coordinators, Data Coordinator (UNM, NMCCA and NMCCA sites)
QA = Quality Assurance
Reg = Regulatory Coordinator
Rx = Pharm Staff

Standard Operating Procedure Documents
No. GENERAL ADMINISTRATION OWNER DATE WHO NEEDS TO REVIEW
1.1 Preparing, Maintaining and Training on SOP’s CRO Director
NMCCA Exec Director
3.15.14 Mgr
1.2 Responsibilities of the Research Team CRO Director
NMCCA Exec Director
3.15.14 ALL
1.3 Training and Education CRO Director
NMCCA Exec Director
3.15.14 Mgr
1.4 Conflicts of Interest in Research CRO Director
NMCCA Exec Director
3.15.14 ALL
1.5 Investigator and Investigative Site Requirements NMCCA Exec Director 3.15.14 Mgr, Reg
1.6 Cooperative Group Participation NMCCA Exec Director 3.15.14 Mgr
1.7 NMCCA New Study Process NMCCA Exec Director 3.15.14 Mgr
 No. STUDY START UP  OWNER  DATE WHO NEEDS TO REVIEW
2.1 Assessing Protocol Feasibility NMCCA Exec Director 3.15.14 Mgr, Reg
2.2 PreStudy Site Visit (PSSV) NMCCA Exec Director 3.15.14 ALL
2.3 Site Initiation Meetings and Visits NMCCA CRS 3.15.14 ALL
2.4 Study Activation NMCCA CRS 3.15.14 Mgr
2.5 Completing an FDA Form 1572 NMCCA CRS 3.15.14 Reg, QA, Mgr
2.6 Submitting a New Study Application to IRB NMCCA CRS 3.15.14 ALL
2.7 Federally Required Website Registration UNM CRA 3.15.14 Mgr, Reg
2.8 Protocol Review and Monitoring Committee CRO Director 3.15.14 ALL
2.9 ARCHIVED
 No. PROJECT MANAGEMENT  OWNER  DATE WHO NEEDS TO REVIEW
3.1 Interactions with Institutional Review Boards NMCCA CRS 3.15.14 ALL
3.2 Clinical Subject Records Nurse Manager 3.15.14 ALL
3.3 Monitoring Visits Nurse Manager 3.15.14 ALL
3.4 Study Termination (Close Out) Visit UNM CRS
NMCCA CRS
3.15.14 ALL
3.5 Investigational Drug Accountability, Storage, Dispensing and Return Research Pharmacist 3.15.14 Mgr, Rx
3.6 Handling of Amendments and Revisions NMCCA CRS 3.15.14 ALL
3.7 Electronic Correspondence HRPO and GCRC NMCCA CRS 3.15.14 Mgr, Reg
3.8 Long Term Storage CRO Director 3.15.14 ALL
3.9 External Adverse Events NMCCA CRS 3.15.14 Mgr, Reg
 No. SUBJECT MANAGEMENT  OWNER  DATE WHO NEEDS TO REVIEW
4.1 Informed Consent – Development and Implementation Nurse Manager
NMCCA CRS
3.15.14 ALL
4.2 Subject Recruitment and Eligibility Nurse Manager 3.15.14 Mgr
4.3 Subject Management While on Study Nurse Manager 3.15.14 Mgr
4.4 Adverse Event Reporting Nurse Manager 3.15.14 POD, Reg, QA, Mgr
4.5 Specimen Collection, Handling and Disposal UNM CRS 3.15.14 Mgr
4.6 ARCHIVED
4.7 OPEN
4.8 Protocol Deviation Reporting and Prevention Nurse Manager 3.15.14 POD, Mgr, QA, Reg
4.9 Emergency Use of An Unapproved Investigational Drug or Agent NMCCA Medical Director 3.15.14 POD, Mgr, QA, Reg, Rx
 No. DATA MANAGEMENT  OWNER  DATE WHO NEEDS TO REVIEW
5.1 Evelos Disaster Plan Velos DB Administrator 3.15.14 Mgr
5.2 Evelos Accounts and Passwords Velos DB
Administrator
3.15.14 Mgr
5.3 Evelos Case Report Form Development and Completion Monitoring Nurse Manager 3.15.14 Mgr
 No. QUALITY ASSURANCE  OWNER  DATE WHO NEEDS TO REVIEW
6.1 Triennial Group Audits Quality Assurance Manager 3.15.14 Mgr
6.2 Internal Audit NCTN Group Clinical Trials Quality Assurance Manager 3.15.14 POD, Mgr, Reg, QA, Rx
6.3 Assuring Subject Safety – Investigator Initiated Trials Reg, POD, QA
6.4 Preparing for an FDA Audit Quality Assurance Manager 3.15.14 Mgr
6.5 Quality Assurance Program Quality Assurance Manager 3.15.14 Mgr
6.6 Making a Hand Written Error Correction Quality Assurance Manager 3.15.14 Mgr
 No. BUDGET MANAGEMENT  OWNER  DATE WHO NEEDS TO REVIEW
7.1 Research Patient Billing Procedures Program Manager 3.15.14 ALL