1. Considerations about Physical and Human Resources. Diana M. Gauto, MD International Clinical Trial Workshop Córdoba, Argentina Sep 11-13, 2014

2. Clinical research investigators need to ensure they have the necessary staff and facilities to successfully conduct a clinical trial.

3.  How to do it?  Negotiation.  No more clinical trials for me

4. “Fair Market Value: the price for which property would exchange between a willing buyer and a willing seller, each having reasonable knowledge of all relevant facts” InformationAccuracyTransparency

5.  Security of patients  Quality of data  FMV  Anti-bribery/ Anti-corruption laws

6.  Physical Resources  Permanent facilities and equipments  Facilities for a specific trial  Logistic  Human Resources  Permanent staff  Hired for a particular trial. Specialist from the area Other staff

7. Permanent from the site Waiting room Exam room. Medical equipment/facilities (eg, calibrated scales, thermometers, EKG, freezer). Drug/device storage (locked space). Secure storage for study records. Archiving Workspace for clinical research staff/ CRA Lab space/access to labs.

8.  Facilities for a specific trial  Infusion room  Crash cart  Access to MRI, CT scan, specific lab tests, etc (vendors)  Logistic  Study Documents  Biological samples

9.  Permanent Staff  Principal Investigator  Study coordinator  RSU/SSU specialists  Pharmacists  IRB/IEC  Delegated staff to collect, handle, storage and transport biological samples. (if applicable)

10.  Hired for a specific trial  Sub-Investigators  Specialized nurses  Physicians form other areas (cardiologists, surgeons, pathologists, hepatologists, radiologists, etc). Specific evaluations Managing AE

11.  Overhead  Start-up fees  Annual/biannual renegotiation of the budget, specially for long terms trials.  Screening failures (if applicable)  Adverse events  Continuation of the site.

12.  Analize and consider all your site and staff´s needs in order to develop the trial.  Information + Accuracy+ Transparency= FMV= Less time in budget negotiation.  Consider re-negotiation for long term trials.  Budget Template

13. Do not be afraid to reject a Clinical trial if the deep analysis you´ve done does not meet your objectives. REMEMBER… Accurate Budget: Early initiation Correct development Preserve Staff Site Data

14.  Thank you very much