Version No: 1.0 / Clinical Research Centre / Page 1 of 4
Date: dd/mm/yyyy / Guideline for Attending & Documenting HRDA / WI-G-2-01-01

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The Director, Clinical Research Centre

WORK INSTRUCTION FORATTENDING AND DOCUMENTING HUMAN RESOURCE DEVELOPMENT ACTIVITY

  1. Identification Of Training
  2. Head of Department (HOD) identifies essential Human Resource Development Activity (HRDA) relevant for new staffby referring Appendix A. Staff files copy of Appendix Ain staff’s personnel file.
  3. Staff should actively seek information from social media on HRDA relevant to the staff’s duties.
  4. Staff must strive to achieve the minimum of 7 days’ training set for all government staff.
  1. Preparation To Attend HRDA

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2.1Staffcompletes a CRC-PS-06-B(01) form (refer SOP-R-G-2-01), submits for endorsement of HOD and then for approval for Institution Director (DI).

2.2After obtaining approval from DI, staff completesand submitsregistration form to organiser of HRDA.

2.3Staff submits (i) completed CRC-PS-06-B(01) form with DI’s approval, (ii) organiser’s invitation letter, and (iii) HRDA brochure to NCRC Finance Unit for the issuance local purchase order (LPO). Staff makes arrangement to send LPO to organiser of HRDA. If organiser does not accept LPO, staff discusses with the Finance Unit for alternate payment modes of payment.

2.4Where relevant, staff completes and submits forms for permission to travel out of office and reservation of flight tickets, for endorsement of HOD and approval of DI.

  1. Completion Of Training
  2. Staff must obtain completed LPO and invoice from HRDA organiser to be submitted to the Finance Unit for payment.
  3. If applicable, staff completes and submits travel claim forms to the Finance Unit before the 10th of the following month after completion of the HRDA.
  4. Staff must completeKKM/P&P/2013 (A) form (see SOP-R-G-2-01) within 1 week after the completion of HRDAand submits to HOD for endorsement.
  5. Staff then submitsHOD endorsed KKM/P&P/2013 (A) form to NCRC Human Resource Unit to be compiled and submitted to MOH’s Training Management Division at year’s end.
  6. Staff completes relevant section of competency assessment form KKM/P&P/2013 (B) form (see SOP-R-G-2-01) 3 months after completion of the HRDA and submits to HOD to complete the other sections of the form.
  7. HOD submits completed KKM/P&P/2013 (B) form to NCRC Human Resource Unit to be compiled and submitted to MOH’s Training Management Division at year’s end.
  8. Staff prepares copies of HRDA certificate and:
  9. File copy in staff’s personnel file
  10. File copy in investigator site file (ISF) if HRDA is a requirement of an industry sponsored research that staff is currently participating in.
  11. Submits copy to Human Resource Unit, NCRC, to be filed in staff’s service record book.
  12. Staff updates HRDA attended in NCRC HRDA database and in staff’s personal Training Log Book and MyCPD (if relevant).

APPENDIX A

NCRC ESSENTIAL HUMAN RESOURCE DEVELOPMENT ACTIVITIY LIST

A / CORE TRAINING LIST
1. / Orientation program for new CRC staff
Information technology security and email etiquette
Research and clinical trial introduction
Microsoft Office Words, Excel, Access (where applicable)
NCRC standard operating procedures (SOP) training
Soft skill training
Report/ manuscript writing
2. / Staff working not more than 3 years in NCRC
Literature search
Basic Research Methodology and Biostatistics
Intermediate and Advanced Statistics
Medical Writing
Critical Appraisal workshop
Basic Good Clinical Practise (GCP)
Data management
National Medical Research Registry (NMRR) registration
3. / Staff working more than 3 years in NCRC
Intermediate Statistics and Advanced Statistics
GCP for research team
NMRR Reviewer training
Other Clinical Trial Trainings relevant to role in clinical trial
B / RESEARCH TEAM MEMBERS TRAINING REQUIREMENT- INVESTIGATOR
NCRC clinical research SOP Training
GCP
Good Practices for Clinical Research (GPCR)
Ethical and regulatory concerns of clinical trial
Role of research team members
Informed consent and consent process
Protocol deviation and violation
Safety and reporting issues
Clinical trial audits/visits
C / RESEARCH TEAM MEMBERS TRAINING REQUIREMENT- SITE COORDINATOR
NCRC clinical research SOP Training
Project Management
-Role of research team members
-Good documentation practice
-communication with sponsors/ clinician/staff
-Visit schedules
GCP
GPCR
Ethical and regulatory concerns of clinical trial
Informed consent and consent process
Protocol deviation and violation
Safety and reporting issues
Clinical trial audits/visits
Lab preparations and shipping
Clinical procedures and policies
Abnormal test results
Drug accountability
Study patient evaluation
Study Coordinator Workshop
D / RESEARCH TEAM MEMBERS TRAINING REQUIREMENT- RESEARCH NURSES
NMRR registration
Research and clinical trial introduction
Ethical and regulatory concerns of research and clinical trial (R&CT)
Protocol review for R&CT Nurses
Informed consent and consent process
GCP/GPCR for R&CT Nurses
Protocol deviation and violations
Safety and reporting issues
Clinical procedures and policies
Abnormal test results
Soft skill trainings
One year*clinical trial attachment with an established clinical trial nurse as mentor
(*If attended any certified Clinical Trial Nurse course the period of attachment may be reconsidered)