Regulations in Clinical Research:Obligations and Responsibilities of

Investigators

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

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- 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…

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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:

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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.

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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

● 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

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Ensuring and protecting the rights, well-being, and safety of human subjects;

Main Investigator Responsibilities

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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);

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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

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Making sure that the investigational drugs are controlled;

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Making sure that all the informed consent forms are properly obtained in accordance with 21 CFR 50;

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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

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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);

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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;

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

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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

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

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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;

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- 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:

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;

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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

‘’The objective of this ICH GCP Guideline is to provide a unified standard for the

European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in

these jurisdictions.”

‘’The principles established in this guideline may also be applied to other clinical

investigations that may have an impact on the safety and well-being of human

subjects.”

‘’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.”

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ICH GCP - E6 Good Clinical Practice: Consolidated Guidance

As the Guideline itself declares:

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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 GCPSponsor responsibilities: ICH E6

contains more details regarding monitoring and QA in clinical trials

when compared to FDA regulations;

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.

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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

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.

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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.

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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

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;

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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

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FDA and ICH requirements for documentation submitted to the IRB

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

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Form FDA 3674 (represents a Certification of compliance with some FDA submissions):http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048364.pdf http://www.fda.gov/RegulatoryInformation/Guidances/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

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✔ 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!

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Lose or delete original data entries!ꭗ Delegate sensitive and important activities to non-physicians ꭗ

(activities that can compromise the study participants or protocol)! Allow any changes to data without a reason why or without checking ꭗ

the originals! 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!ꭗ

DON’T!

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

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…’’

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

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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;

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

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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;

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

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- 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

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.

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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.’’

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Poor Warning Letter Responses

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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!

Disqualification of the Investigator

According to 21 CFR 312.70, an investigator can be disqualified when:

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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;

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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

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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.

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- 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

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- 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

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- 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

Running Clinical Trialshttp://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

FDA Basics for Industryhttp://www.fda.gov/ForIndustry/FDABasicsforIndustry/default.htm

Sign up for Updateshttp://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234630.htm

Replies to Inquiries to FDA on Good Clinical Practicehttp://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/RepliestoInquiriestoFDAonGoodClinicalPractice/default.htm

FDA Inspections of Clinical Investigators - Information sheethttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf Guidance for Industry - Investigator Responsibilitieshttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf 42

FDA Websites for More Information

Investigator-Initiated Investigational New Drug (IND) Applications webpagehttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm343349.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA Debarment List (Drug Product Applications)http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm

Clinical Investigators- Disqualification Proceedingshttp://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm

List of Warning Lettershttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

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FDA Websites for More Information

Regulatory Procedures Manual Section on Warning Lettershttp://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm

Inspection Observationshttp://www.fda.gov/ICECI/EnforcementActions/ucm250720.htm

Inspections Classification Database and Searchhttp://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm

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FDA Websites for More Information

● 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!

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CHECKLIST

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...