Research Execution

1. Assemble your research team

Once you have obtained funding for your study it is a good idea to complete a needs assessment to determine:

  • how much work will there be
  • what are the specific duties
  • what qualifications are needed to perform the duties and work
  • what available resource can be committed to this position

After you have determined the needs for your study you may realize that you have to hire a new employee.  Before making any verbal or written commitments to any individuals it is a good idea to get in touch with your divisional administrator or HR representative to address any questions you may have, and ensure that you are following the necessary UBC guidelines. If you are thinking of hiring an individual who is already a UBC employee please speak with your HR representative to determine the individuals seniority level.

If you have not already done a full budget forecast it is a good idea to determine what the full projected costs for your hire will be for the duration of the project. A full forecast would include an estimate

Research Execution

of full benefits, cost of living increases, mid-point progression increases, merit increases, and tuition waivers.

If you decide to hire a new employee through UBC or post a new position through UBC you will need to complete the following steps:

  • Create the job description
  • Post/advertise the position
  • Establish the interview/selection committee
  • Shortlist candidates
  • Develop interview questions, including behavioral based interview questions
  • Contact candidates
  • Conduct interviews
  • In-basket test (recommended but not required)
  • Reference checking, including the current supervisor
  • Analysis of candidates against the assessment criteria
  • Make the job offer
  • First day orientation

Links & Contact Information

2. Prepare study file documentation

Every research study should have it’s own study file which contains all the key documents for the study. The number and type of documents required will depend on the type of study being done. When conducting a clinical trial your monitor or sponsor will typically assist in the preparation of all required documents. When conducting an investigator initiated trial it is the responsibility of the investigator to ensure that all of the documentation is in place.

The Research Office has prepared a checklist for all essential documents that should be in the study master file for every study which is conducted in the Department of Medicine.

Essential Documents for a Research Study_V1.0

The study master file should be kept in a secure location and maintained for both the duration of the study, and the required storage time period following the completion of the study.

3. Train all individuals involved in the study

Training and documentation of the training is another essential building block of a high quality research. Investigator initiated studies are not exempt from training

  • Every individual who participates in research involving human subjects must complete the TCPS2 Course On Research Ethics (CORE) training.
  • Clinical investigators and other essential study team members should have up-to-date ICH – GCP training certificates on file. These certificates are valid for 2 – 3 years and are proof that you understand your responsibilities and obligations.
  • All study team members including the PI should be trained on relevant SOPs and the study protocol.
  • All training should be documented in a training log, signed and dated by all trained individuals, in accordance with training SOPs.

Training may be done through the Network of Networks (N2) and the Collaborative Institutional Training Initiative (CITI). Through CITI investigators and research staff may access any of the following training modules:

  • Good Clinical Practice (GCP) *must have this training*
  • Health Canada Division 5 Course
  • Human Subjects Research – Biomedical
  • Human Subjects Research – Social & Behavioral
  • Transportation of Dangerous Goods/International Air Transport Association
  • Responsible Conduct of Research

UBC, VCHRI and PHCRI are members of N2 and thus as employees you have access to this very important resource.

Setting up an account and completing the courses:

  • You may create a CITI account and select either VCHRI, PHCRI or UBC as your institution or organization. You may add multiple organizations, but will only have one account. Each institution receives confirmation that you have completed the course
  • You can work at your own pace, at home, over lunch or during a designated training time frame
  • You must achieve a mark of > 80% to pass the modules. Once you complete the course you will receive a printable certificate. Print off the certificate and include this in your training file

Troubleshooting:

If you are having trouble accessing these resources please contact the Research Office

4. Recruit participants

Recruitment of participants is often the most challenging of the research execution steps. Remember that all recruitment materials must be approved by the REB before use.

VCHRI can assist VCH investigators with the recruitment process by listing your study on their Active Clinical Trials Registry, or sending  an “E-blast” out notices to all VCH staff about studies which are currently enrolling participants.

5. Study & follow-up visits

For all participant study and follow-up visits it is the responsibility of the research team to ensure proper documentation. Remember that if it is not written down, it did not happen.

6. Monitor study progress, quality systems & update accordingly

It is very important that throughout your study you take time to ensure that your quality systems are in place. Are there deviations from the protocol or SOPs, are these deviations documented, and what corrective and preventative actions have been implemented to address the deviations? In a quality or systems audit you will be measured against what you say you will do in your protocol and SOPs, so it is important to ensure that these match with your actual working practice.

Remember that if you need to update or revise your protocol or add a study team member that you must complete a Post Approval Amendment (PAA) of your ethics application in a timely manner.The UBC CREB website has a number of helpful guidance documents for how to deal with protocol deviations, unanticipated problems and how to report adverse events.

7. Study Completion and Termination Procedures

At the completion of a study the PI is responsible for notifying the UBC REB of record, and the institution (if required), and completing a Study Completion PAA. Studies at a VCH site must also complete a Notification of Study Completion or Termination form.

Please refer to the CREB Guidance for Study Completion to determine when a study may be considered complete, and requirements for data retention.

Audit and Inspection Preparedness

All registered studies, whether investigator or sponsor initiated may be subject to audit or inspection, by a sponsor, Health Canada, or a foreign agency. While this not a frequently occurring process it is important to carry out your research practices as though it may occur.

The BC Clinical Research Infrastructure Network (BCCRIN), and VCHRI have collaborated to create an Audit and Inspection Preparedness Program (AIPP). In addition to workshops, the program provides researchers with resources needed to prepare for an audit or inspection including, checklists, educational materials, SOPs and a very detailed manual. Individuals who wish to access these resources may contact the Research Manager.

If a  research group is expecting an audit/inspection they should inform the following individuals (if applicable):

  • Sponsor
  • Institution Representative (VCHRI) Stephania Manusha or (PHCRI) Esther Wu
  • Hospital Management
  • Medical Records
  • IT Department / Security
  • Pharmacy
  • Storage (if records are in storage facility external to site)
  • Department Research Manager (jody.swift@vch.ca)