Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial. For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.

1. Regulations in Clinical Research:
Obligations and Responsibilities of
Investigators

2. Two of the most important individuals in a clinical trial are
investigators and sponsors. However, being such a crucial part of a
trial also brings many obligations and responsibilities. Although the
sponsor is the one who initiates and finances a trial, the investigator
is the person who conducts it. For this reason, most of the
obligations and responsibilities fall on the investigator as the person
accountable for everything that goes wrong in a trial. Learning these
obligations and knowing how to follow them is a crucial practice that
will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give
you a basic outline of all the rules and regulations that investigators
and sponsors should follow.
Introduction
2

3. - Recognize the federal obligations associated with clinical research and
investigators;
- Learn which are the most common problems at clinical research sites
that occur during an FDA inspection and ways to avoid them;
- Use different methods that will ensure working with compliance with
all protocol requirements and federal regulations;
After reading this, you’ll be able to…
3

4. The Investigator in a clinical trial is the person
who’s responsible for the actual conducting of
the study. The study drug is distributed to the
human subjects under the Investigator’s
immediate directions.
Even though some trials might be led by more
than one individual (a team), still, there has to
be one person who’s responsible for the
whole trial and this person will be the study
investigator.
While we’re on the subject of defining
investigators, there is one common question
that we feel deserves an answer:
4
Defining an Investigator
Can physicians be investigators?
YES! Physicians are allowed to be sub-investigators, but
they will only perform the procedures for which they
have the necessary knowledge and medical expertise. So,
not only medical doctors, but also physicians can be
investigators.

5. 5
The sponsor of a clinical trial can be not
only an individual, but also a company,
institution, or an organization (such as a
CRO) which firstly initiates, and then
manages and/or finances the trial. As
such, the sponsor is usually not the one
who actually conducts the research. This
role is usually carried out by the
investigator. Later, we’ll talk more about
the tasks and responsibilities of sponsors
in a clinical trial.
In some cases, one individual can be both
the initiator of a study and the person
who conducts it. This individual will be
called a sponsor-investigator. When this is
the case, that individual takes the tasks,
obligations, and responsibilities of both
roles - sponsor and investigator. [21 CFR
312.3]
Defining a Sponsor Defining a Sponsor-
Investigator

6. ● Federal Food, Drug, and Cosmetic Act (FD&C Act) - represents a set of
laws which gives authority to the FDA (US Food and Drug Administration) to
supervise, oversee, and inspect the safety of food, drugs, and cosmetics.
- Section 505(i) is where the FDA is given a statutory authority to supervise
and oversee clinical studies in order to test and inspect their effectiveness
and safety.
● CFR (Code of Federal Regulations) - a set of regulations under Section
505(i) which outline the authority of the FDA over the clinical studies
conduct. In these regulations are also included:
- Investigator responsibilities;
- Sponsor responsibilities;
● Other guidances - as advice that will help investigators and sponsors to
work with compliance and conduct the study according to all regulations;
6
Clinical Studies Legal Framework

7. 7
Ensuring and protecting the rights,
well-being, and safety of human
subjects;
Main Investigator Responsibilities
#2
#1
As we’ve said before, clinical investigators are the people who carry out and conduct the
actual research, and as such they have a great number of obligations and responsibilities
to fulfill. Here are some of the most important investigator responsibilities in a trial:
Making sure that the whole
research/investigation is being
conducted in accordance/compliance
with:
- Form 1572 - Signed Investigator
Statement
- Investigational plan;
- All applicable regulations (below);

8. 8
Controlling and making sure that all
requirements regarding reports,
approval, and IRB submission and
review are met, according to 21 CFR 56;
Main Investigator Responsibilities
#4
#3
Making sure that the investigational
drugs are controlled;
#5
Making sure that all the informed
consent forms are properly obtained
in accordance with 21 CFR 50;

9. 9
Creating Investigator reports according to
21 CFR 312.64:
- Progress reports which are given to
the sponsor;
- Safety reports (reporting any less
serious adverse events according to
a previously specified timetable as
well as urgent reports for any serious
or complicated adverse events);
- Giving a final report to the sponsor;
- Giving a financial disclosure to the
sponsor according to 21 CFR 54;
Main Investigator Responsibilities
#7
#6
Keeping/retention of records (21 CFR
312.62):
- Records of drug disposition;
- Case histories;
- Relevant data on each subject that
received the study drug;
- Relevant data on each employee that
controls the investigation;
- (keeping the data 2 years after the
date when the marketing application
is approved for the drug - only for the
indication that it was researched for);
- (keeping the data 2 years after a
discontinued investigation);

10. 10
Choosing and selecting an
investigator that has the proper
qualifications to lead the trial;
Keeping/maintaining an effective IND;
Main Sponsor Responsibilities
According to 21 CFR 312.50, sponsors are responsible for:
Providing all the necessary
information to investigators in
order to be able to properly
conduct the investigation;
Making sure that the whole
investigation is properly and
consistently monitored;
Making sure that research is being
conducted according to the general
investigational plan;
Making sure that both the
investigator and the FDA are timely
informed of any important/relevant
new adverse events/risks to subjects;

11. The FDA has certain expectations that the Investigator must follow.
The most important and basic FDA expectation is ACTING
IN ACCORDANCE WITH The Code of Federal Regulations
(CFR)!
Compliance with the CFR means to learn, know, and adhere to all
clinical investigator regulations, and to learn, understand, and
respect all clinical investigator responsibilities.
Investigators and the FDA
11

12. 12
FDA Expectations: Study Oversight
● Supervision on how the study is being conducted;
● Training of all the study staff;
● Delegation of study tasks as appropriate;
● Oversight of third parties involvement;
FDA Expectations: Protecting the Rights, Welfare, and Safety of Subjects
● Avoid the exposure of subjects to redundant and unneeded risks;
● Facilitate and provide medical care for any issues that arise from study participation (adverse events);
● Provide medical care for other non-study-related medical problems that can occur during the study;
FDA Expectations

13. This statement notes:
‘’No investigator may participate in
an investigation until he/she provides
the sponsor with a completed, signed
Statement of Investigator, Form FDA
1572 [21 CFR 312.53(c)]’’.
Statement of Investigator
Form FDA 1572
13
Investigator Commitments on 1572:
- Notify and inform all subjects that the drugs
will be used for investigational purposes;
- Always conduct or supervise the investigation
personally;
- Make sure that all the individuals who are
working and assisting with the study conduct
are always informed of their appropriate
obligations;

14. 14
- Ensure that you always follow the exact protocol and do not make any changes before
informing the sponsor, unless human subjects are at risk;
- Make sure that the subjects understood and signed the Informed Consent Form (21 CFR Part
50), ensure IRB review, reports, and approval (21 CFR Part 56);
- Inform the sponsor about any adverse events (21 CFR 312.64); read/understand the IB;
- Ensure that all records are maintained adequately and accurately (21 CFR 312.62) as well as
available for future inspections according to 21 CFR 312.68;
- Ensure the initial and all the other reviews by the IRB and inform them of any research
changes or unexpected issues that could put human subjects at risk, and don’t make any IRB-
unapproved changes, unless if it’s urgently needed to avoid hazards to subjects;
- Work/act in accordance to all other requirements in 21 CFR 312;
Investigator Commitments on 1572:

15. Do you need a Form FDA 1572?
This is a common question asked by many foreign clinical studies. Below, you’ll see the three most
common cases regarding the Form FDA 1572.
A clinical study conducted outside of the U.S. and is not under an IND (investigational new drug
application) - THE INVESTIGATOR DOESN’T NEED TO SIGN A 1572;
A clinical study conducted outside of the U.S. but is under an IND - THE INVESTIGATOR HAS TO SIGN A
1572 (along with respecting all other FDA IND regulations);
A clinical study with a local law prohibiting the 1572 - FDA WILL EXPECT THAT THE SITE OPERATES AS A
NON-IND SITE;
15

16. 16
Good Clinical Practice or GCP represents an
international quality standard.
In the case of clinical trials and their safety on
human subjects, GCP follows the guidelines
provided by ICH - INTERNATIONAL CONFERENCE ON
HARMONISATION OF TECHNICAL REQUIREMENTS FOR
REGISTRATION OF PHARMACEUTICALS FOR HUMAN
USE.
ICH GCP - E6 Good Clinical Practice: Consolidated Guidance

17. Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.”
ablished in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of hum
‘’The guideline was developed with
consideration of the current good clinical
practices of the European Union, Japan, and
the United States, as well as those of Australia,
Canada, the Nordic countries and the World
Health Organization (WHO).”
‘’This guideline should be followed when
generating clinical trial data that are
intended to be submitted to regulatory
authorities.”
17
ICH GCP - E6 Good Clinical Practice: Consolidated Guidance
As the Guideline itself declares:

18. 18
Delegation of informed consent: The
FDA has no specific regulations when it
comes to investigators who delegate
informed consent activities or in other
words - it ‘’does not require the
investigator to personally conduct the
consent interview’’. However, ICH E6
does allow investigators to delegate the
informed consent process to an
appropriate person.
Signing the informed consent
form: In this area, the FDA
regulations don’t require that
the person who conducts the
informed consent process signs
the form, while ICH-GCP does
require this action.
Delegation of activities related to the
investigational drug: While the FDA
has no regulation regarding such
activities, the ICH permits the
investigator to delegate the
dispensing of study drugs, counseling
of patients, and drug accountability to
an appropriate individual;
IRB area: In this section, FDA
regulations are more
detailed and with more
requirements;
Differences Between FDA regulations and E6 ICH GCP
Sponsor responsibilities: ICH E6
contains more details regarding
monitoring and QA in clinical trials
when compared to FDA regulations;

19. REMEMBER!!!
GCP (Good Clinical Practice) as an official quality standard in all FDA-regulated trials is not
equivalent to good clinical practice in the sense of caring for patients. An example for this are the
FDA requirements in regards of drug accountability, following of the study protocol,
recordkeeping, etc.
19
Differences Between FDA regulations and E6 ICH GCP
Investigators should be careful of the following:
FDA-regulated research standards
≠
Clinical care of patients standards
≠
Academic research standards

20. Back in History: The Thalidomide tragedy (1961-1962) - A Lesson on
Drug Safety
Thalidomide is a drug which was first introduced in the post-war
period mostly as a safe sedative (among other conditions). This
drug was first spread on the German market, but soon after it also
entered other countries as well as the U.S. It even started selling
as an over-the-counter drug. The tragedy here is that it was also
presumed to be safe for the pregnant mother and her unborn
child, especially once the drug was promoted to help with
morning sickness. However, this wasn’t the case. In 1961, doctors
around the globe started associating Thalidomide with birth
defects in babies whose mothers were taking this drug during
pregnancy. Thalidomide caused approximately 10.000 babies
(reported cases) to be born with phocomelia (limbs
malformation), out of which only 50% survived. This tragic case
was the first step that led to a more strict and regulated drug
control.
20

21. Back in History: The Thalidomide tragedy (1961-1962) - A Lesson on
Drug Safety
The Food, Drug and Cosmetic Act of 1938 was now proved to have a huge loophole - companies being able to
distribute still unapproved drugs for experimental purposes. This Act also didn’t require that the patients are
informed of the fact that a drug still holds an investigational status nor did it require the FDA to be informed of
this experimental use. Another loophole area is the fact that this Act didn’t require any kept records such as
keeping track of distribution of the drug. And lastly, the Act didn’t require any demonstration of the
effectiveness of a certain drug.
21

22. 22
Requirements:
- FDA has to be informed before a clinical
trial is conducted;
- FDA is allowed to inspect company
records related to clinical research and
development;
- Drug approval will be now based on
both efficacy and safety;
- Authority and rulemaking over
‘’Investigational New Drugs’’;
- Rulemaking authority over clinical trials
and research;
- FDA has the power to stop clinical trials;
Requirements:
- Current framework of clinical
research was created;
- Investigators participating in clinical
trials have to be qualified and
possess the required scientific
training and experience;
- All trials have to be controlled and
adequate;
- Informed Consent forms are
required for all human subjects who
will participate in a clinical trial;
- Keeping of records is now an
obligation;
Actions taken to Regulate the Approval Process of Drugs
Kefauver-Harris Drug Amendments
Act in 1962
IND Regulations of 1963

23. The Investigator as the Person in Charge at the Site
Many parties interested in starting a clinical research site are always wondering who is the person in charge at the
site. We are here to tell you that this person is the investigator!
Not only that the investigator is in charge at the clinical research site, but he’s also responsible and held
accountable if things go wrong!
Although sponsors are allowed by the FDA to delegate their actions to CROs (contract research organizations,
investigators are not allowed to delegate their responsibilities and tasks to other outside organizations, individuals,
or site staff.
If the investigator isn’t doing his/her job properly, or is delegating tasks that should be performed personally, the
FDA will give penalties for noncompliance (posted on the FDA website). These penalties can be:
- Warning Letters;
- Disqualifications/Restrictions/Debarments;
- Criminal prosecutions/prison/fines;
23

24. FDA requirements:
- Complete documents that the investigator
receives (the protocol, investigator’s brochure, a
sample of the informed consent form, all
advertising materials that are to be distributed);
- Progress reports;
- Reports of any injuries to subjects;
- Reviewed research proposals and any scientific
evaluations;
ICH requirements:
- All written information distributed to subjects;
- Informed consent forms;
- Protocol and all amendments;
- Advertisement materials;
- Investigator’s Brochure;
- Information regarding payments/compensations
to subjects;
- Current CV and qualifications of the investigator;
24
FDA and ICH requirements for documentation
submitted to the IRB

25. Reporting Clinical Trial Results
( www.ClinicalTrials.gov )
The U.S. Public Law 110-85 states that a responsible
party (usually the sponsor or PI) should register and
report any results of so-called ‘’applicable clinical trials’’
on www.ClinicalTrials.gov .
More information:
http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa
An FDA-required statement in the informed consent:
http://www.fda.gov/downloads/RegulatoryInformation/
Guidances/UCM291085.pdf
25
Form FDA 3674 (represents a Certification of
compliance with some FDA submissions):
http://www.fda.gov/downloads/AboutFDA/ReportsMa
nualsForms/Forms/UCM048364.pdf
http://www.fda.gov/RegulatoryInformation/Guidance
s/ucm125335.htm
For more questions regarding registration and results
of clinical trials - NLM Helpdesk:
http://clinicaltrials.gov/ct2/helpdesk?hd_url=http%3A
%2F%2Fclinicaltrials.gov%2Fct2%2Fmanage-
recs%2Ffdaaa
For compliance and/or enforcement:
gcp.questions@fda.hhs.gov

26. 26
✔ Conduct sensitive research activities personally!
✔ Supervise all research activities personally!
✔ Respect and follow the current study protocol!
✔ Make sure that everyone who assists the conducting of the study knows their obligations!
✔ Meet all informed consent requirements according to 21 CFR 50 as well as all requirements
concerning IRB review, reporting, and approval!
✔ Always notify the study sponsor AND the IRB in advance and get their approval if you wish to
make any protocol changes!
✔ Make sure that you possess a signed informed consent form for every human subject that’s
participating in your trial!
✔ Inform the sponsor about any adverse events that might occur during the study conduct!
✔ Always keep and maintain proper and accurate records and have them ready for inspection
at all times!
✔ Respect every single requirement in 21 CFR 312!
✔ Finally, report all financial worries and interests to the sponsor!
DO!

27. 27
ꭗ Lose or delete original data entries!
ꭗ Delegate sensitive and important activities to non-physicians (activities that can
compromise the study participants or protocol)!
ꭗ Allow any changes to data without a reason why or without checking the originals!
ꭗ Backdate any informed consent forms and/or signatures!
ꭗ Make protocol revisions without a written approval from sponsors!
ꭗ Neglect/omit to secure an IRB approval of all consent form revisions!
ꭗ Ever use study staff as subjects (participants) in a study!
DON’T!

28. Compliance vs Non-Compliance: Inspections and Audits at the Site

29. Compliance vs Non-Compliance: Inspections and Audits at the Site
According to Section 505(k)(2) of the Food, Drug and Cosmetic Act, the
FDA is granted the rights to access, copy, and verify all necessary
records in a clinical trial!
21 CFR 312.68 states that:
‘’An investigator shall upon request from any properly
authorized officer or employee of FDA, at reasonable times,
permit such officer or employee to have access to, and copy
and verify any records or reports…’’
29

30. Compliance vs Non-Compliance: Inspections and Audits at the Site
30
Most Common Questions Asked During an Audit/Interview
(Authority Delegation - WHEN/WHERE/WHO)
- Staff training;
- Informed consent forms of study subjects;
- Pre-screening/Screening of subjects for enrollment;
- Test article receipt - administration/handling/return;
- Reports/safety reports;
- Transcription of data;
- Archiving data;
- Laboratory;

31. Compliance vs Non-Compliance: Inspections and Audits at the Site
31
Most Common Slips that Cause Non-Compliance
- Lack of supervision and oversight;
- Insufficient or improper training of study
staff;
- Inability to protect the safety and well-being
of study subjects;
- Poor investigator involvement in the study;
- Study staff and investigator being
overworked, thus unable to perform at their
best;
Outcomes - Classification of Compliance
During an inspection, studies can be separated into
three different groups depending on their level of
compliance with regulations. The results of your
inspection can be classified as:
- NAI (no action indicated): working in
compliance;
- VAI (voluntary action indicated): small deviation
that requires voluntary correction where
necessary;
- OAI (official action indicated): major/critical
non-compliance which will require FDA
involvement;

32. Compliance vs Non-Compliance: Inspections and Audits at the Site
32
- Warning letter;
- Notice of Initiation of Disqualification
Proceedings and Opportunity to Explain
(NIDPOE);
- Disqualification of clinical investigator;
- Criminal Investigation by Office of Criminal
Investigations (OCI);
- Debarment;
Regulatory Actions for Non-Compliance

33. Form FDA 483
After the inspection, the FDA will either estimate that there’s no action indicated or you’ll be given an FDA Form 483.
On this form, it is noted that it:
‘’...lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional
observations, and do not represent a final Agency determination regarding your compliance.’’
The person who receives this FDA Form 483 will have to send back a response to the FDA. This response should be
submitted within 15 days of receiving the 483, no matter how many items and observations it includes. The response
submitted based on this Form should contain either a specific correction timeline or a further explanation and
clarification of the FDA requirements.
By providing the FDA with a good response on the 483, you might be able to prevent receiving a warning letter!
Even though the 483 is to be taken seriously in order to prevent any further complications, it does not represent a
final FDA decision on whether the FD&C Act has been violated in any way. The FDA Form 483 together with all
responses from your site will be then gathered and the FDA will decide if there should be any other actions taken.
33

34. Warning Letter
The FDA Warning Letter is an official document that usually follows an inadequate response of FDA Form 483. This
document is defined as:
‘’...a correspondence that notifies regulated industry about violations that FDA has documented during its
inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency
considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug,
and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be
issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the
documented violations are not promptly and adequately corrected.’’
34

35. Poor Warning Letter Responses
35
After this letter is received, you should always aim to give the best answer that’s supported by facts.
However, in practice, there have been many wrong responses to this Warning Letter. Here’s what not to
respond:
- Blaming the study monitor for issues regarding IRB approval;
- Blaming the study coordinator for activities that belong to you as the investigator;
- Enrollment of study participants/subjects based on your (as an investigator) personal opinion,
when these subjects do not meet inclusion criteria;
- Submitting false information to sponsors (such as reporting that you’ve enrolled subjects who
never showed up, changing and manipulating other subject data, etc.);
- Enrolling ineligible subjects (especially in trials where more serious drugs are involved - oncology
trials) - this can cause serious adverse events and even death;
- Altering the medical records of patients;
DO NOT GIVE THE ABOVE RESPONSES TO A WARNING LETTER!

36. Disqualification of the Investigator
According to 21 CFR 312.70, an investigator can be disqualified when:
36
He/she fails to comply
with FDA requirements
repeatedly and/or
deliberately;
The FDA gives timely notice
to the investigator for an
informal hearing in order to
explain his/her actions;
The FDA then
provides a chance for
formal hearing;
Finally, when all of these options
are exhausted, the investigator can
be disqualified and lose the
eligibility to receive investigational
drugs in the future;

37. 37
Kornak was a VA (Veterans Administration) researcher and study coordinator at the Stratton VA
Medical Center in Albany, New York. He was conducting oncology trials and was altering patient’s
medical records and blood tests so that they can be enrolled in his trials. However, one of the
patients had a severely impaired liver and kidney function, so when he received the harmful oncology
drugs he died. For this crime, as well as many other fraudulent actions, Paul Kornak was sentenced to
71 months (almost 6 years) in prison, as well as debarred from any further clinical research. His
associate, Dr. Holland, was also given 5 years probation.
Case Study: Paul H. Kornak - Jail time for fraud

38. 38
Case Study: Paul H. Kornak - Jail time for fraud
Throughout his years of conducting research,
Kornak admitted to altering a minimum of 27
patient records. Furthermore, Kornak was also
posing as a physician, while in reality he never
finished his medical education and training.
This case study should serve as the perfect
example of what not to do to all researchers out
here. Every researcher should know that when it
comes to patients’ safety and fraud, they’re going to
be held personally accountable and responsible for
everything that goes wrong.

39. 39
- Be involved and supervise the trial;
- Select and employ qualified staff;
- Provide proper training to staff members;
- Make sure that your staff only performs activities they’re qualified for;
- Ensure that sub-investigators and staff are involved;
- Consider the human factor when handling systems;
- Try to not handle data too often in order to avoid human errors;
- Try to avoid conflicts of interest;
- Make sure that you estimate the ability of both staff and systems to comply with: protocols, subject
visits, FDA inspections, EDC systems, laboratory testing and data, archiving data, reports to the
sponsor, recordkeeping, drug accountability, etc.;
- Use systems that don’t allow space for human errors;
Ensuring Quality Data and Subject Safety in Trials

40. 40
- Standardize all systems used in order to ease data input and review by all parties;
- Try to simplify the protocol;
- Note all procedures (SOPs) and use checklists whenever possible;
- Double-check all CFRs and consent forms against every change that you notice;
- Create an integrated framework;
- Develop: Data Management Plan, Data and Safety Monitoring Plan, Data Analysis Plan, and Quality
Assurance Plan;
- Train, test, do beta-testing;
- Always have a backup plan regarding floods, disasters, staff turnover, etc.;
- Be careful of unblinding procedures;
Ensuring Quality Data and Subject Safety in Trials

41. 41
- Gather weekly meetings with your team/staff;
- Be your own audit;
- Implement and use a system that will detect
and correcting errors in real time;
- Follow and audit all changes (who, why, what,
when);
- Close loops and take care of monitoring
queries;
Ensuring Quality Data and Subject Safety in Trials

42. Running Clinical Trials
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
FDA Basics for Industry
http://www.fda.gov/ForIndustry/FDABasicsforIndustry/default.htm
Sign up for Updates
http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234630.htm
Replies to Inquiries to FDA on Good Clinical Practice
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/RepliestoInquiriestoFDAonGo
odClinicalPractice/default.htm
FDA Inspections of Clinical Investigators - Information sheet
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf
Guidance for Industry - Investigator Responsibilities
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM18
7772.pdf
42
FDA Websites for More Information

43. Investigator-Initiated Investigational New Drug (IND) Applications webpage
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Appro
valApplications/InvestigationalNewDrugINDApplication/ucm343349.htm?source=govdelivery&utm_me
dium=email&utm_source=govdelivery
FDA Debarment List (Drug Product Applications)
http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm
Clinical Investigators- Disqualification Proceedings
http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm
List of Warning Letters
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
43
FDA Websites for More Information

44. Regulatory Procedures Manual Section on Warning Letters
http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm
Inspection Observations
http://www.fda.gov/ICECI/EnforcementActions/ucm250720.htm
Inspections Classification Database and Search
http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm
44
FDA Websites for More Information

45. ● Investigators are the most important people in a clinical trial and their attitude and compliance will
affect the quality of the study itself!
● Clinical trials are a serious business that brings positive or negative outcomes to people who need
new, safe and effective ways of treatment!
● Every investigator, sponsor, coordinator, and all other staff working on a study should be familiar
with working under the appropriate FDA regulations!
● GCP (Good Clinical Practices) in clinical research is not equivalent to standard good care of patients!
● Both the sponsor and the investigator should know their responsibilities and obligations as well as
their accountability!
● Every investigator is in charge at the site and he/she is the one responsible for the whole study
conduct!
● Always follow the appropriate FDA/ICH regulations!
● Address and correct all FDA issues in a timely manner in order to prevent further complications!
● ALWAYS ensure quality data and maximum safety to your study participants!
45
CHECKLIST

46. We sincerely hope that we’ve managed to give you
enough information on the regulations and safety
measures regarding clinical trials. Clinical research is an
extremely important field in medicine which should be
taken seriously since it has a great impact on improving
and advancing treatments. To sum up, we now know
that the most important person in a clinical research is
the investigator since he/she is the one who’s
conducting the actual study. The investigator carries
almost all accountability when it comes to working in
compliance with rules and regulations. Hopefully, we’ve
given you an idea of what the main obligations and
responsibilities of a good investigator are and you can
use this in order to improve your study. Finally, in clinical
research it’s important that we all remember to generate
quality data and take care of the safety and well-being of
patients.
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As a final note...