Managing clinical research requires acquiring studies, selecting sites, and setting up regulatory and operational processes. Key steps include business development to find studies, signing confidentiality agreements, completing feasibility surveys, undergoing site selection visits, negotiating contracts and budgets, establishing regulatory documents and staff training, conducting study start-up activities, hiring coordinators, and ensuring proper conduct through monitoring visits, database locks, closeouts, and payments. Effective management requires timely responses, active business development, and strong relationships with sponsors.

1. Managing the
Clinical Research
Process
From Startup to Closeout

2. Clinical Research Essentials
In order to manage a clinical
research process, you will need:
● A research site
● A PI
● A study coordinator
● A study

3. 1. Business Development: Acquiring Studies
● Without studies, you cannot generate
revenue!
● You can hire a service to help with acquiring
studies, or do it yourself.
● Go on clinicaltrials.gov, drugdev.org, or other
databases
● Search for indications and open studies
● Contact and network with project managers
that are looking for research sites
● Play the numbers game

4. Acquiring CDAs
● CDA: Confidentiality Disclosure Agreement (sometimes called NDA)
● Sponsors will send you CDAs as a formal document to inform you that
they are about to send confidential information about a study which
should not be shared
● Keep in mind: even though you have signed an NDA, you are still allowed
to forward the study contact to a colleague, just not the protocol or study
synopsis.
● Check your email!!! CDAs should be reviewed and returned back to the
sponsor as soon as possible!

5. Feasibility Survey
● Returning the CDA will likely trigger a
feasibility survey
● A feasibility survey is how the sponsor
gauges your site’s capabilities:
○ Your Investigator’s experience
○ Your coordinator’s experience
○ Your patient database numbers
○ Your previous study experience
● They are primarily looking for: patient
recruitment capabilities and clinical
research experience

6. 2. Site Selection Visit
● Once the sponsor reviews your feasibility
survey and determines that you are a worthy
site, they may contact you to arrange for a
site selection visit
● This visit may be done remotely via phone call
● In most cases the sponsor will want to tour
your site and meet with your PI in person
● Once again, be sure to respond in a timely
manner!

7. After the SSV...
● You will receive a site selection letter letting you know whether or not
you were awarded the study
● How soon after the SSV will vary
○ Could be on the day of the SSV or months later
● Typically, new sites will take longer to get a response vs add-on sites
● If it is up to you to follow up if you have not heard a response

8. Always Take on More Studies!
● Always try to take on more studies
than you think you can manage
● With the prevalence of risk-based
monitoring, studies may end much
sooner than when they were
scheduled to end
● Studies may be ended due to low-
efficacy or safety reasons
● If you end up with too many studies,
you can always lower recruitment

9. 3. Contracts and Budgets
● Always negotiate your contracts and
budgets!
● Never just accept what is offered
because they will give you every
excuse to pay you less
● Always try to turn around your
negotiation of your contracts and
budgets within 1-2 weeks

10. 4. Startup Regulatory
● The sponsor will send you a startup regulatory package which will include:
○ 1572
○ Financial disclosure forms
○ IRB Questionnaire
○ Site Delegation Log
○ Other essential documents
● These documents should be completed before your site initiation visit (SIV)
● Make sure the PI, Sub-I, and all relevant staff sign off on these forms
● Make sure you send in your initial IRB submission so that your site can be
approved
● Again, make sure this is done within 1-2 weeks

11. Other Essentials
● At this point, the sponsor will likely have sent
you other essentials for the study:
○ Regulatory binder
○ Lab kits
○ Investigational product
● Staff Training
○ ECG training
○ EDC training
○ GCP training
○ IATA training
● Make sure you have these things in place
prior to the SIV

12. 5. Site Initiation Visit
● At this visit, the monitor visits your site to:
○ Conduct protocol training
○ Ensure you are fully equipped with lab kits, source docs, and study supplies
○ Ensure you have all regulatory documents in order
○ Ensure that your staff have EDC and IWRS access
○ Review your SOPs (Standard Operating Procedures)
● Essentially, they come to make sure you have everything you
need to start screening patients
● If anything is lacking, the monitor will let you know in their
follow up letter what action items need to be completed before
your site can start screening patients

13. 6. Source Documents
● You could outsource for the creation of source
documents or make them yourself although
this can be time consuming
● Reference the Schedule of Assessments chart
in the protocol
○ Don’t forget to read all the footnotes!
● Ask the sponsor for eCRF guidelines or
screenshots of the EDC system to fine tune
your source docs
● Follow your own SOPs

14. 7. Hire a Coordinator
● It will be difficult to manage study activities/subject
visits while handling business development as well
● Always actively tend to business development
because studies are prone to closing out early --
have something lined up
● The coordinator is the backbone of any study and
will do 90% of the work
● Your coordinator will determine whether your site
is a green, yellow, or red light site.

15. 8. Interim Monitoring Visits
● Every 6-8 weeks on average, a
monitor will visit your site to:
○ Do source data verification
○ Monitor your EDC and query any
discrepancies
○ Ensure you are following the protocol
○ Review your regulatory binder and make
sure all training and documents are up to
date
● Your relationship with your CRA is
critical!

16. 9. Database Locks
● At certain points in the study, monitors will
require all data up to that point to be entered,
free of queries, and locked
● During database lock weeks, monitors will be
issuing a lot of queries and contacting you
frequently to ensure that all data is entered so
that it can be frozen.

17. 10. Study Closeout Visit
● Will occur after all data has been
source data verified.
A CRA will visit your site to:
● Collect any remaining IP
● Send out a close out report to the IRB
● Conduct a final check of your
regulatory documents

18. 11. Invoicing and Payments
● Depending on the study and on your contract/budget, you may or may not be
able to invoice for screen failures, transportation, and other line items
● Some studies require invoicing and others pay automatically
○ SDVed study visits when entered in EDC may trigger payments
● Every contract is different so make sure you negotiate effectively from the start