E-regulatory is the electronic documentation. Regulatory documents include the principle investigator’s medical license, CVs or resumes and most importantly the FDA form where investigator is saying that he is taking complete responsibility of the sites, a delegation of authority log where investigator states that he is the delegating authority to its other colleagues in the office to be able to perform physical exams, labs for himself and pulmonary function testing.
Delegation of authority log should be backed up with the evidence that the delegated people are having appropriate education, schooling and training to be able to perform those functions.
Mistakes can occur on paper:
Most regulatory binder these days is papers where there are more chances to making mistakes as below:
1. Delegating authority to a person with no experience and education to perform pulmonary function testing.
2. Expired license or unable to reviewing and renewing the information in the documents.
These mistakes can be prevented by using electronic regulatory binders.
Electronic regulatory binder:
This medium is useful in many ways as below:
1. People getting reminders, notifications and messages through the computer if their license is near to expiry date. This also notifies is someone’s license is expired.
2. Electronic regulatory documents can contain the documents, certifications, licenses and experience information on status of a person that enable us to know if a person is capable of delegating authority for a responsibility.
3. Improves the quality of research.
Sites are the actual beneficiaries of the site’s investment into electronic regulatory documentation. This helps the sites to elevate their performance and professionalism in industry.