Scientific Research Data Collection

I. SCOPE OF APPLICATION / TARGET APPLICANTS

• Research projects directly managed or hosted by the University of Medicine and Pharmacy at Ho Chi Minh City.

• Research projects conducted by undergraduate and postgraduate students from other educational institutions whose supervisors are current staff members of the Hospital.

II. REGULATIONS ON APPLICATION DOSSIERS AND TEMPLATES

1. Application for Research Data Collection Permission

• Letter of Introduction issued by the governing/managing body of the research project (Original copy)

• Application for Research Data Collection by the Principal Investigator/Investigator (Original copy)

• Research Data Confidentiality Undertaking Form by the Principal Investigator/Investigator (Original copy)

• Ethical Approval Letter issued by the Institutional Review Board / Ethics Committee in Biomedical Research (Photocopy)

• Research Protocol / Study Proposal and Appendices (Electronic copy)

• Data Collection Form / Case Report Form (CRF) used in the study (Electronic copy)

• Participant Information Sheet and Informed Consent Form (ICF) (Electronic copy)

• Official Decision on Study/Training Deputation for staff currently working at University Medical Center HCMC (Photocopy)

• Other relevant scientific and legal documents concerning the research (if applicable)

Electronic submissions (as indicated above) must be sent to:

Pham Thi Quynh Nhu – Department of Science and Training (4th Floor, Block A)

Telephone: (+84-28) 3952 5384 | Email: nhu.ptq@umc.edu.vn

2. Requests Arising During Data Collection

• Application for Addition of Research Sites / Data Collection Locations (Original copy)

• Application for Extension of Data Collection Period (Original copy)

• Application for Medical Record Extraction for Scientific Research (Original copy)

3. Post-Data Collection Requirements

When completing procedures to verify the list of study subjects, investigators shall submit one of the two forms below depending on the study population:

• Application for Verification of Research Subjects as Patients/Medical Records Used in Scientific Research (Submitted to the Planning and General Affairs Department) (Original copy)

• Application for Verification of Other Non-Patient Subjects (Submitted to the Department of Science and Training) (Original copy)

4. Submission Schedule and Venues

• Working Hours:

  • Morning: 07:00 – 11:30

  • Afternoon: 13:30 – 16:30 (Saturday: Morning only)

• Venue: University Medical Center HCMC (215 Hong Bang St., Cho Lon Ward, Ho Chi Minh City)

• Dossier Receiving Coordinators:

  • Department of Science and Training (4th Floor, Block A): Pham Thi Quynh Nhu | Tel: (+84-28) 3952 5384 | Email: nhu.ptq@umc.edu.vn

  • Planning and General Affairs Department (Medical Records Archive – 14th Floor, Block A): Le Phuong Dien | Tel: (+84-28) 3952 5369 | Email: dien.lp@umc.edu.vn

III. GENERAL REGULATIONS

1. Information Confidentiality

• The Principal Investigator (PI) / Investigator is responsible for maintaining information confidentiality throughout the entire research lifecycle. For studies requiring data that could potentially identify patients or hospital staff, the investigator must provide a detailed data management and confidentiality plan.

• The investigator must not share research data with any third party or organization without prior written authorization from the Hospital.

• Any form of publication, report, or adaptation must de-identify and exclude all personally identifiable information (PII) of patients and hospital personnel.

2. Copyright and Intellectual Property

• All secondary data extracted from physical medical records, electronic medical records (EMR), and other modalities collected at the Hospital remain the proprietary property and copyright of the Hospital.

• Whenever data collected at the Hospital is utilized for research or publication, investigators must explicitly cite the data source and secure prior written approval from the Hospital.

• To guarantee the accuracy and academic integrity of publications derived from data collected at the facility, the Hospital reserves the right to require at least one (01) hospital staff member to participate as a co-investigator and co-author on the resulting publication.

3. Disciplinary Actions for Non-Compliance

• Any protocol deviation or violation committed by investigators during study conduction at the Hospital will be reported to the Department of Science and Training. Depending on the severity of the violation, data collection may be temporarily suspended or permanently terminated at the Hospital.

• Investigators bear sole direct and indirect liability toward study subjects and under Vietnamese law for any consequences arising from non-compliance throughout the research implementation at the Hospital.

• Investigators who violate data collection regulations may be disqualified and barred from conducting any future research at the Hospital.

IV. STANDARD OPERATING PROCEDURE (SOP) / IMPLEMENTATION WORKFLOW