Find your way around a research study
For research coordinators and support staff in hospitals, clinics, units and field-care settings.
See who usually does what on a study, how to recognise an approved study document, where study training comes from, and who to ask when something does not add up. Examples use Harborview Health, a fictional organization, and a fictional study, HV-204. The approved direction for your own study always takes precedence over this page.
Four things staff usually need
Plain summaries of what each topic below covers.
- Who coordinates day-to-day study activity
- Who supports scheduling and records
- Who to hand a clinical question to
- Which document types a study uses
- How to check a version before you use it
- What to do when two versions disagree
- Study-specific training from the study team
- Role-based research training
- Systems access and refreshers
- Start with the role closest to the question
- Escalate when the first route cannot resolve it
- Keep a short written trail
Who does what on a study (sample setting)
Illustrative roles at Harborview Health. Titles and divisions of work differ by study and site.
| Role | Usually handles | Hands off to |
|---|---|---|
| Research coordinator | Day-to-day study activity, participant scheduling, keeping study files current | Principal investigator for clinical judgement |
| Research support staff | Scheduling help, filing, preparing materials for visits | Research coordinator for study questions |
| Principal investigator | Clinical oversight and decisions about the study | Clinical Operations for site-level issues |
| Study support lead | Document control, training records, answering process queries | Clinical Operations and Support Services |
Approved study documents: what to check first
Confirm the current approved document through your study's controlled source and document-control process. Your coordinator can direct you to that source and the authorized role for version questions.
- Find the version number and date on the document itself.
- Compare them with the current version listed by your study team.
- Use the study's controlled copy, not a saved or emailed one.
- Stop using both copies until the question is settled.
- Tell your research coordinator what you found and where.
- Let the study support lead confirm which version is current.
Where study training comes from
Training is assigned by role and by study; ask your coordinator or study support lead what applies to you.
Study-specific training
Role-based research training
Systems access and refreshers
Worked example: a document-version question on Study HV-204
A fictional illustration of coordination between a coordinator and the study support lead. It is not policy.
-
1
Notice the mismatch
A research support assistant preparing materials for a visit sees that the printed instruction sheet says version 3, dated in March, while the study folder lists version 4. -
2
Pause and tell the coordinator
The assistant sets the printed sheet aside and sends the coordinator the document title, both version numbers and where each copy was found. -
3
Coordinator checks the controlled set
The coordinator compares the sheet against the study's controlled list and cannot confirm which version applies, so asks the study support lead. -
4
Support lead confirms and records
The study support lead confirms version 4 is current, has the old printed copies removed, and notes the correction in the study file. -
5
Close the loop
The coordinator tells the assistant which version to use and tells anyone else who handled the old copy.
Queries and escalation: where to start
Start with the first route. Escalate when it cannot resolve the question. Response times are set by your study and site, not by this page.
| Kind of question | Start with | Escalate to |
|---|---|---|
| Which document version is current | Research coordinator | Study support lead |
| Training I am missing for a study | Your manager or study support lead | Clinical Operations and Support Services |
| A clinical question about a participant | Principal investigator or the trained clinician for the study | Study-approved escalation route |
| Scheduling or records for a visit | Research support staff lead | Research coordinator |
| A problem that crosses studies or sites | Study support lead | Clinical Operations and Support Services |
Common questions from new research staff
Can I use a document I found in my email or on a shared drive?
Use the study's approved controlled source and document-control process. A matching version number or date on an emailed or saved copy is not enough to establish that it is authorized for use. Ask the research coordinator or study support lead to confirm the approved source when you are unsure.
I am not clinical. Do I still need study training?
Possibly. Training follows your role and the study you support. Ask your manager or study support lead which sessions apply to you.
What do I write down when I raise a query?
Keep it short: what you saw, where you saw it, which study it relates to, and who you told. This helps the next person pick it up without asking you again.
Who owns this page?
Clinical Operations and Support Services owns this orientation. If something here does not match your study's approved direction, tell your study support lead so it can be reviewed.