New Employee General Information
New to Clinical Research

Doctors that perform drug studies to aid Pharmaceutical Companies to bring new experimental chemical entities to drug store shelves as new medications to be prescribed by doctors and purchased by patients are called the PI (Principal Investigator). The drug study process is referred to as an IND (Investigational New Drug). Their medical office is referred to as a Site. The Drug Company Sponsoring the experimental drug study is referred to as the Sponsor. It is a common practice for the Sponsor to hire another company to perform their Sponsor related drug study activities called a CRO (Contract Research Organization). The patient who steps forward to volunteer to be among the first to try a new experimental drug is referred to as a RSV (Research Subject Volunteer). The rights and welfare of the RSV are guarded by the IRB (Institutional Review Board). The IRB approves the ICF (Informed Consent Form). The ICF is the document the RSV signs on their initial visit that outlines the risks, benefits and alternative procedures concerning their illness and guides them on their decision to volunteer for the study or not.

The person that helps the doctor at the site conduct the drug study is called the CRC (Clinical Research Coordinator). There is an organization that provides CRC’s with board certification called the ACRP (www.ARCPNet.org). The degree is called: CCRC (Certified Clinical Research Coordinator).

The typical CRC is a MA (Medical Assistant) who can draw blood, perform vital signs, perform EKG, etc…. There are some that are not, however. More desirable ones hold a Nursing Degree and are licensed.

There is also an RA (Research Assistant). The RA helps manage the data in the CRF (Case Report Form). RA’s have limited clinical contact with patients. Some RA’s go on to become RAC’s (Regulatory Affairs Coordinators). There is an organization that certifies RAC’s called, PRIMR (www.PRIMR.org). The RAC functions to deal with the regulatory affairs type of paperwork that outlines the responsibilities among the Sponsor, CRO, and the Site. FDA form 1572 is a contract between the site and the FDA that describes the PI’s responsibilities. Another type of RA is the QA (Quality Assurance) Manager. The QA manager function is to plan, implement, and evaluate the sites clinical quality assurance program. The manager is responsible for auditing the site's operations to determine if they are compliant with the companies' SOPs (Standard Operating Procedures), quality programs, and applicable regulations. This provides a quality check to assure the site is conducting the research in accordance with all the proper rules and regulations that are applicable from the Sponsor, CRO, IRB (Institutional Review Board) and any other governing body. Still another sub-type of RA is the Advertising and Marketing Associate. The Marketing and Advertising Coordinator function is to help recruit new research subject volunteers to join experimental drug studies. The ideal candidate would have knowledge of subject recruitment strategies within the ethical confines of IRB approval along with advertising and marketing experience.

The representative from the Sponsor Pharmaceutical Drug Company that audits our work is called a CRA (Clinical Research Associate). Certified CRA’s are called CCRA (Certified Clinical Research Associate).

If the PI at a site makes an error the FDA may sanction the PI with a 483. The 482 is the notice the FDA is coming to audit the site. Typically the Sponsor attempts to conduct a pre-FDA audit themselves if time allows. A PI that doesn’t perform the studies in accordance with the rules can be black listed so they may never be listed on a 1572 to perform a trial again. This is why there are some many layers of checks and balances to assure the study is conducted proper. The goal is to provide the CRO with the data the Sponsor can bring to the FDA to support their NDA (New Drug Application) that is accurate, easily verifiably, documents that the experimental research protocol was followed and truly reflects what occurred.

In summary, the drug study process is very complex. It acknowledges there is risk for a patient to take an experimental drug. It seeks to inform a potential research subject of these risks and what alternative procedures are available to them. It looks to manage this risk and to minimize it as much as possible as to safe guard the RSV. This is possible through the hard work and interrelationships among:

1. RSV (Research Subject Volunteer)
2. PI (Principal Investigator/Research Doctor)
3. CRC (Clinical Research Coordinator)
4. RA (Research Assistant)
5. RAC (Regulatory Affairs Coordinator)
6. QAC (Quality Assurance Coordinator)
7. MAC (Marketing and Advertising Coordinator)
8. IRB (Institutional Review Board) (Central vs Local)
9. Sponsor (Drug Company)
10. CRO (Contract Research Organization)
11. CRA (Clinical Research Associate/CRO’s Representative)
12. FDA (Food and Drug Administration) www.FDA.gov

Sincerely:

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRP
PI (Principal Investigator), DSI (Drug Study Institute)
Board Certified Internist, JPMC (Jupiter Preventive Medicine Center)
DABIM (Diplomat American Board of Internal Medicine)
FACP (Fellow American College of Physicians)
CPI (Certified Physician Investigator) by the AAPP (American Academy of Pharmaceutical Physicians)
CCTI (Certified Clinical Trial Investigator) by the ACRP (Association of Clinical Research Professionals)
CCI (Certified Clinical Investigator) by the DIA (Drug Information Association)
CCRC (Certified Clinical Research Coordinator) by the ACRP (Association of Clinical Research Professionals)
CCRP (Certified Clinical Research Professional) by SoCRA (Society of Clinical Research Associates)
Founder, CertifiedResearchers.com
IRB Member, Jupiter Medical Center
Ethics Committee Member, Jupiter Medical Center
Member, ARENA (Applied Research Ethics National Association)
Member, PRIM&R (Public Responsibility in Medicine and Research)
Member: The American College of Preventive Medicine
Expert Medical Witness, ExpertMD