Updated CRA Interview set 2023

What does each element of ALCOA mean, and how are they implemented differently for data originally collected on paper vs. first recorded electronically?

(A)Attributable-Is it traceable to a person, date, and subject visit? When documenting data on paper, every written element needs to be traced back to the authorized individual who is responsible for recording it. This requires a signature or initials, the date, and an identifier to a subject visit. Similarly, if something needs to be changed on the record, it needs to be initialed, dated, and should explain the reason for the change. Audit trails in an electronic system make it very obvious who created a record, when it was created, who made a change, when the change was made, and the reason a change was made. A compliant system will automatically track this information and enable electronic signatures. Data is attributable to a unique user with a secure password and role-based permissions, preventing changes from being made by unauthorized users. (L) Legible-Is it clear enough to read? On paper, everything that's written must be easy to read and recorded in a permanent medium (not pencil). Handwriting must be clear to reduce the likelihood of transcription errors and allow a study to be accurately re-created. Electronic source records typically solve the illegible handwriting problem, because data and information are presented in a clean and standardized format. (C)ontemporaneous- Was it recorded as it happened? Data should be recorded, signed, and dated at the time of trial conduct, rather than risk an individual recalling the wrong information from memory. On paper, data needs to be documented in real-time and dated with the current date (no predating or postdating). Automatic date and time stamps support this every time clinical data is entered, edited, or modified in an electronic system that has the appropriate controls in place to fully support compliance with 21 CFR Part 11. (O) Original- Is it the first place data is recorded? The source is the earliest record - the first place that data is documented. If corrections or revisions need to be made, changes shouldn't obscure prior entries. Paper source documents should be preserved and kept in their original form. When the first record is electronic, an audit trail can track any and all subsequent queries and changes. (A) Accurate- Are all the details correct? It's critical that the source completely reflects the true observations. This means an honest, accurate, and thorough representation of facts describing the conduct of the study. There will be times when source documents are incomplete, inconsistent, or wrong. If changes need to be made, modifying a paper record always need to be done in a compliant manner. When the source is electronic, audit trails can provide transparency to prevent data from being altered in a way that is difficult to detect. Additionally, automatic edit checks can immediately alert when missing data points or out-of-range data are entered. All of the elements of the acronym ALCOA must be applied to both paper and electronic source data, and the records that hold that data. Serving as evidence of the events that took place during a study, source documents need to paint the full picture of what happened. Using ALCOA as a guide to collecting quality data in clinical trials can help justify that a test article is safe and effective.

What qualities do you have that make you a good CRA?

1) Multitasking: I have the ability to manage multiple tasks, duties, issues and situations. I believe that this quality is key to being a good CRA. 2) Flexible/adaptability: This quality is critical for a dynamic and fast paced environment like clinical research. Im very adaptable and I assimilate change very fast. 3) Fast learner: able to absorb information quickly and relay to site personnel. 4) Detail Oriented: I am a very meticulous person and I have a good eye for detail 5) Good interpersonal and team playing skills: With the need to manage the different personalities one meets as CRA, including Investigators, Coordinators, Pharmacists, etc, the possession of interpersonal and team playing skills is a very important quality for success.

How many PSSV have you done?

150+

How many SIV have you done?

150+

What is the highest number of sites you've had at any given time?

20.

How far is the airport?

20mins

How many COVs have you performed:

50+ this is different for everyone.

How many IMV have you done?

600+ (this varies depending on your years of experience)

What is your companies days on site requirement?

8 DOS

What are certified signed copies of the EMR. What exactly does that mean?

A certified copy is the original information that has been verified as indicated by a dated signature, an exact copy having all of the same attributes as the original. However, if it is decided to have a certified copy substitute for the original, it would be desirable to have a "standard operating procedure" (SOP) describing how such copies would be made, verified, and documented. The person who certifies the copy as an accurate and complete representation of the original, having all of the same attributes and information, should be the same person who actually made the copy from the original. Certification should be accomplished by having the person who makes the copy, sign or initial and date the copy to indicate it meets the requirements of a certified copy as described above. This should be described in the SOP and can be accomplished by initialing and dating each copy or by initialing and dating a document certifying copies in bulk. Whichever method is used the SOP should describe the procedure. (There are many ways to accomplish this, and the procedures described above are only suggested examples.)

What is ALCOAE?

According to the FDA, data should meet certain fundamental elements of quality. Whether they're recorded on paper or electronically, source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA). If these best practices for source documentation aren't followed, there is no valid evidence that the test article is safe and effective.

What is ICH GCP?

An international ethical & scientific quality standard for trials that involve the participation of human subjects regarding: - Design - Conduct - Reporting & Recording - Monitoring - Auditing - Analysis

How do you feel about the use of animals in pre clinical drug research:

Animal research has had a vital role in many scientific and medicinal advances of the past and continues to aid in our understanding of various diseases. Throughout the world people enjoy a better quality of life because of these advances and the subsequent development of new medicines and treatments all made possible by animal research.

What is an SAE?

Any untoward medical occurrence to a clinical trial subject that 1) leads to death 2) prolonged hospitalization or 3) Hospitalization for more than 24 hours 4) a congenital anomaly 5) Birth Defects 6)Disabilities 7) That is Life threatening 8) Requires intervention to prevent the AE from being life threatening, e.g Emergency Room Visit 9) Any AE that the PI feels that is life threatening to the subject.

Can you explain your responsibility as a monitor for SAEs?

As a monitor I am responsible to ensure SAEs are reported within 24 hours of awareness and followed up with 15 days. All information regarding the SAE should be gathered and reported into the electronic data capture for the sponsor review.

What the closest major Airport to you?

Atlanta Hartsfield Jackson International.

What document does the PI sign and must be in place before the study starts?

CV, confidentiality agreement, financial disclosure forms, medical licenses, documentation of IP and trial related materials shipment, signed informed consent forms, signed HIPAA forms, source documents, signed dated and completed case report forms, interim or annual reports to IRB/IEC and authorities, subject screening log, subject identification code list, signature sheet.

Can you tell me what are some of the essential documents you look for when reviewing the regulatory binder:

CVs, medical licenses, delegation of authority log, training documentation, financial disclosure forms, protocol, protocol signature page, IB, protocol deviation log, temperature logs, 1572 form, Confidentiality agreement.

What is your current assignment/workload?

Currently at the moment I am working on 1 protocol and assigned to 15 sites.

What makes you different from other CRAs.

Due to my broad experience and high technical skills I have been able to create trackers that have been helpful to other CRAs & my study teams. Some of the trackers I have made my studies are still utilizing them. For example I made a tracker to keep track of the current activities going on at sites (Regulatory, Safety, IP etc)

How do you handle a temperature excursion?

During a temperature excursion I follow the following steps: 1. Ensure all affected drug has been quarantined 2. Notify site staff and team 3. Ensure all subjects are contacted to ensure no one has consumed affected drug, and if they did they should be notified to discontinue use of the drug. 4. Retrain the site to ensure it does not happen again 5. Document as a protocol deviation 6. Ensure the site staff reports the deviation to the IRB. 7. Write the deviation in there log and in your report 8. Take all necessary follow-up steps.

What do you do during an IMV?

During an IMV I check informed consent forms, check for SAEs, do source document verification, check the site binder, perform drug accountability, check temperature logs, check site staff changes, resolve any outstanding issues, discuss with the PI.

What is your current region of travel?

East coast, Midwest, south east, north east.

What is your experience working with multiple therapeutic areas?

For the most part of my career I have worked on Oncology studies. Studies involving Solid Tumor, Mantle Cell Lymphoma, Multiple Myeloma, Leukimia. As you can see from my resume, my experience spans across a wide range of therapeutic areas. Syneos, PPD, and ICON encouraged cross-functionality and this is best exemplified in the fact that CRAs are trained to work across therapeutic areas. So at every point in time I was always monitoring multiple protocols from multiple therapeutic areas. Essentially my past roles have enabled me to develop the skill and capacity to work in multiple therapeutic areas & multiple protocols.

Tell me some of the advantages and disadvantages of working from home.

Gives me more control and a greater sense of ownership of my work space and office environment. Research has proven that the suitability of the work environment to an individual's work style can affect productivity and working from home enables me to create the kind of work environment that will best enhance my productivity and this positively impacts my output. However one can miss the camaraderie that exists in an office environment. This is compensated for by the fact that as a CRA you go out to the sites and interact with site staff a few days of the week and this reduces the lonesomeness of working from home.

Your educational background has nothing to do with science or research so how did you learn about this opportunity:

Haha funny enough I get that all of the time. You see while I was in school I majored in Business Administration but I also had a minor in Chemistry. I have always had such a deep interest for science and technology especially since my dad is a Principal Investigator. I was also a Stem Scholars back in college. Being a stem scholar I worked on different research projects with faculty members. Most of the research I did was focused on plants and animals. So really I have always been into science right from my school days.

What is your average days on site-

I am currently doing 10-12 days on site a month.

How good are you with submitting your reports?

I am very good. My reports are usually finalized by the 5th business day because I start my report when I am on site and finish the rest when I leave the site or when I am in my hotel or on the plane.

What percentage are you willing to travel?

I am willing to travel 80%.

What areas do you need improvement in?

I can be very critical of myself. People have often told me that I am self-critical and beat myself up. (e.g Even when I was ill, I still expect myself to meet my commitments and deliver on goals and targets). I have to keep reminding myself that I am human and have limitations or prone to make mistakes, and learn to just pick myself up, learn from situations and move on.

What do you know about our company?

I did a Google search and like that your company takes training very seriously and I am looking for a place to train me properly and help me fully develop my skills. I also feel that your company has a strong therapeutic knowledge in a broad range of indications. I love working for a variety of studies so I would like to make good use of this knowledge.

Where are your sites located:

I do a lot of nation wide travel. I travel about 80% of the time. My sites are located throughout the region like CA, NY, NY, FL, and GA.

Have you ever been involved in any audits?

I have been involved in sponsor audits but I've never been involved in an FDA Audit. What was your role in the audit and what were some of the findings? Well, I performed as the CRA and I helped the site prepare for the audit. I worked closely with them in preparing and made sure they were 100 percent ready. There were no major findings from my audits.

A problem with a PI or site staff and how you resolved it? :

I have not really had a major problem in the PI, however I have been in a situation where I inherited a problem between a PI and a previous monitor. The problem was that the PI is very busy and was usually unavailable to meet with the coordinator during monitoring visits. The previous CRA was confrontational in dealing with this issue and this led to a kind of hostile working relationship. When I inherited this site, I sensed that the PI wanted to transfer this same hostile attitude towards me. So I arranged to meet with the PI to discuss the modalities for my monitoring visits. During this meeting, I decided to adopt a deferential tone and I started by recognizing how important and busy his job is. I told him that in recognition of how busy he is, I will let his schedule determine the days for my monitoring visit. I offered to consult him first with options and he can let me know his availability before I schedule my visits. He was very appreciative of my recognition of his busy schedule and he cooperated with me throughout my monitoring of his site.

What studies have you been dedicated to?

I have worked on Covid-19 (phases I), Mantle Cell Lymphoma (phase I-II), and CKD (phase I-II).

What phases of studies have you worked on?

I have worked on phases 1, 2 and 3.

Where do you expect to be in the next 5 years?

I hope to have grown in my knowledge and experience as a Clinical Research Personnel and to have been promoted accordingly with a higher level of responsibility. Basically I'd love to grow with the company and five years from now feel proud about my contribution to the achievements of the company and the personal growth and development I have achieved in that process.

How do you learn something new?

I learn something new by really going into detail and learning it. For example if I am given a new study I do not only take the trainings the company offers via there online learning management portal, I also go further and do more trainings on my own. I take additional online trainings by watching videos about the indication, learning information about the disease on Khan academy. It is important I feel extremely prepared so I am able to answer any question and full understand the protocol.

What did you like best in your last job?

I liked the environment and the people I worked with. My study team in particular was really great to work with. My CTM & I were able to build up a great rapport as the study was in start up.

What do you like best about site monitoring?

I love the 'dynamic nature of site monitoring. I love the fact the fact that I get to meet new people, and I am often faced with different challenges and issues involving multiple sites, different protocols,

How do you communicate with sites?

I make sure I communicate with my sites on a weekly basis , either via email and phone calls. When I communicate with my sites via phone call, I make sure to document my telephone contact in the form of a followup email which I will send to the sites.

Can you tell me how did you learn to become a CRA-

I started off as a CRA I. I took a CRA I intense training program. I was training on ICH and GCP regulations. I performed FDA trainings as well. I went on several observational visits for every type of monitoring visit, where I was able to observe the different monitoring skills and techniques different CRAs possess. Then, I was signed off and assessed by a manager before I could start working independently as a monitor.

How do you stay organized?

I stay organized prioritizing things based on the level of importance and deadlines. I keep track of my deadlines and site visits via my Microsoft outlook calendar, I set daily goals for myself, I make use of my outlook reminder. To track the activity of a site I use an excel spreadsheet.

What additional training or conference have you attended to further your knowledge or skills-

I take additional trainings within my company.

What experience do you have with TMFs?

I use the trial master file to run TMF reports that show outstanding documents that need to be collected from the site. Also CRAs were responsible for uploading all collected documents to VeevaVault using a TMF naming convention.

What is the frequency of your site visits?

I visit my sites every 4-6 weeks.

Why did you get into clinical research?

I was attracted to clinical research by the fact that it affords me the opportunity to contribute to the improvement of human health and welfare. The knowledge that my role contributes to the development of a safe and effective material for improving the health of the sick is self-fulfilling to me.

What do you enjoy most about clinical research?

I was attracted to clinical research by the fact that it affords me the opportunity to contribute to the improvement of human health and welfare. The knowledge that my role contributes to the development of a safe and effective material for improving the health of the sick is self-fulfilling to me. Hearing the different success stories makes you want to get up and go another day.

If offered the position how soon can you start:

I will need to give my company a two week notice.

What would you do If your site was unable to provide you with access to the EMR?

I would ask the site if they have paper source documents and/or I will ask the site to provide me with printed certified signed copies of the EMR.

Are you a in-house CRA or a home-based/field CRA?

I'm a field based CRA not an in house CRA

What Therapeutic areas and phases have you worked in?

I've worked in several therapeutic areas including: Cardiology/Vascular, Hematology/Oncology, Respiratory, Nervous System, Vaccine. I have also working on the following indications and phases: : Covid-19 (Ph1), Solid Tumor (I-II), Mantle Cell Lymphoma (I), Coronary Artery Disease (Ph I), Venous Thromboembolism ( Ph I-II), Chronic Kidney Disease (Ph 1-2) phases I, II, and III clinical trials.

What would you do if you suspected fraud?

If I suspected fraud I would ensure the site staff and my team/sponsor is aware of all of my findings. I would also escalate it to the audit team and see if an auditor can come out to re-review my findings.

What kind of errors are found in your report?

If my report is returned back to me for corrections there are usually very minimal errors found like maybe I forgot to update a comment on an outstanding issue and action.

Have you ever suspected fraud?

If so what did you do and what was the outcome? I have never had a site that committed fraud but I have suspected it before. I was on site performing an IMV and I saw that all of the subjects who signed consent the signatures looked very similar. The signature of the Sub-Is giving consent also looked alike. So I crossed check the signatures with there signatures on the Delegation of Authority Log, Financial Disclosure Forms, CVs, and other documents that required their signatures. Fortunately there was no fraud being committed but I did bring it to the sites attention.

What are the requirements for EMR access?

It is important that each CRA is given their own unique username and password. They should only have access to the subject for that study and site. Access should not be given to every single subject. Access should be read only.

Tell me about one of the most difficult sites/institutes you have worked with?

MD Anderson. It was difficult because they give their CRAs a really hard time when it comes to scheduling visits. Also they hire a lot of newbies in the research industry which leads to a lot of errors. There was once in the month of Mar-2016 they were not allowing any CRAs to come out there because of the change in EPIC system they were having. That is why I always make sure I schedule all of my visits several months in advance with my sites.

What clinical trial management systems do you use (CTMS)?

Medidata Rave CTMS is my favorite. I have experience with Impact, Bioclinica, Ceebo, eclincal, Infolink 2, , Right Track II---you only need to mention three.

What EDC systems do you have experience with?

Medidata Rave, Inform, Omnicomm, and Datalabs

What do you think is the most challenging aspect for a CRA?

Most people complain about travelling, but to me that is the most exciting part. I love to travel and see different parts of the country often visiting places I would never imagine going to. I prefer that over an office job where the routine is very predictable.

Where is your furthest site?

My furthest site is in California.

What is the highest number of protocols you have worked on?

My highest number is three.

Tell me about your self:

My name is Victor and I have over 12 years of monitoring experience. My research experience started when I was working as a study coordinator for Emory University Teaching Hospital. As a coordinator I was mainly dedicated to oncology clinical trials in phases I and II. While working as a coordinator a CRA opportunity presented itself to me with PPD. PPD was looking for CRAs that had minimal experience or SC (study coordinator) experience. I applied and was hired as a CRA I. I went through their CRA Bridge training programing which involved me having to perform observational monitoring visits for each of the visit types. I also flew into their Raleigh, NC office where I did two week in house training. The remaining of my training was done from home using their online learning management system. After my training was completed I began to co-monitor for a while before finally being signed off by a Senior CRA. The training took me about 4 months before I could start working independently. Since I've been a monitor I've worked in several therapeutic areas including: Cardiology/Vascular, Hematology/Oncology, Respiratory, Nervous System, Vaccine. I have also working on the following indications and phases: : Covid-19 (Ph1), Solid Tumor (I-II), Mantle Cell Lymphoma (I), Coronary Artery Disease (Ph I), Venous Thromboembolism ( Ph I-II), Chronic Kidney Disease (Ph 1-2) phases I, II, and III clinical trials.

What is your team comprised of?

My team is made up of 10 CRAs, 2 project managers, and 1 Clinical Trial Manager. I report to my line manager for any company concerns or if am not meeting my metrics.

Do you have a preference between to early stage and late stage research?

No

Have you ever had a late report?

No

Will you require sponsorship in the future?

No

What is your perception of a typical day as a CRA?

No day is the same for a CRA. On a day that a CRA designated for site visit, it is expected that the CRA should get to the site in time, well dressed and ready for monitoring duties. At each interim visit, the CRA is expected to verify informed consent for new patients, perform source document verification for all visits since the previous monitoring visit, perform drug accountability, retrieve all updated essential and regulatory documents, retrain site personnel on all areas of deficiencies. On the other hand, on a day that is not designated for site visit, a CRA might be in-house writing up reports for previous visits, taking calls from sites and providing answers to their question, replying emails from the site and sponsor as required, scheduling future site visit, updating tracking documents for sites under his/her management.

Have you over missed a deadline?

No, I am extremely organized which has resulted in me never missing a deadline.

Do you have any experience with paper CRFs?

No, I only have experience with eCRFs.

Did you start off as a CRA III?

No, I was hired as a CRA I then progressed into a CRA.

DO you currently have any pending offers?

No, but I am actively interviewing at the moment. I currently have a final interview with IQVIA at the end of the week.------it is important you tell them you are interviewing with other companies so as to speed the process. When they see you have other interview it will make them want to move faster.

So are you saying at the moment the current company you are at does not give you room for growth?

No, that's not what im saying. There is room for growth with my current company. I just didn't feel properly supported. I believe this company lacks good communication styles and I am very big on communicating.

Are you interviewing for a permanent or contract position?

Permanent

How do you go about getting access to your sites EMR?

Prior to my visits I will ensure I contact my sites several weeks in advance regarding their EMR system and how I can receive access. Usually sites will provide a form to fill out asking for your name, social security, date of birth etc. After that is filled access is usually given. Each CRA is given their own unique user name and password.

What rating scales do you have experience in?

Rating Scales are assessment tools to measure the reliability, validity, and responsiveness of clinical trials in terms of their intended outcomes on patients. Rating scales are used in several other types of research studies

What is risked based monitoring and how is it used?

Risk-based monitoring is when you target your monitoring activities, which might sometimes include 100% Source Document Verification (SDV) in certain cases, where they are going to deliver the greatest benefit to the study. You can do this by looking at the risks (KRIs) to the study represented by each site and by the type of data that you're collecting to decide where you monitoring effort would be best used. As more data is analyzed during the course of the study, the risk based monitoring strategy may change in order to give more attention to the most critical elements of the study. The idea of risk-based monitoring is to pinpoint parts of the protocols where they anticipate a site to have a lot of problems, adverse events, or protocol deviations. It is a more proactive approach. As more risked-based monitoring studies come out, there are going to be less on-site monitoring visits. That's where the remote monitoring visits come in, and ultimately, this is the arena where virtual workspaces will serve a very important purpose in allowing the entire workflow of a clinical trial to run as smoothly as possible from the site initiation process to the study closeout. -- In risk-based monitoring, the idea is to more efficiently utilize the CRA's time, whether they be on site or in a virtual workspace. CROs and sponsors use things such as risk-trend analysis to see which sites are causing a lot of the protocol violations or if there are certain safety issues that are going on with study participants. They look at certain adverse events of interest or certain data points. There are people crunching the numbers in the (electronic data capture) EDC systems to analyze each site as well as all of the sites in aggregate. This way, sponsors can be more proactive in telling the CRAs what they should be paying attention to when they visit a site.

What is source document verification?

Source document verification is checking the data in the source document versus checking the data in the EDC.

What is the submission timeline of trip reports?

The initial trip report is due in 5 business days and the final trip report is due in 5 business days.

Who reviews your trip report?

The lead CRA on the study or the CTM reviews the trip report.

What do you not like about site monitoring?

The number one challenge in site monitoring is unexpected travel issues, the occasional flight delays which could be very annoying. Or rental car issues, etc. But being an "On the go kind of person", the excitement of traveling compensates for this challenge.

What is the purpose of the FDA Form 1572-

The purpose of the 1572 is a form that must be filled by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S food and drug administration (FDA) code of federal regulations for the clinical trial. The investigator verifies that he or she has the experience and background needed to conduct the trial and that it will be done in a way that is ethical and scientifically sound.

What are essential documents:

These are the documents needed for clinical trials to be carried out eg. 1572, FDF, delegation of Authority Log.

Why are you looking for a new job at this time?

Well I am currently looking for a new job because I am looking for a company where I can grow both personally and professionally. In the next 5 years I would like to work as a Clinical Trial Manager so I want to make sure I am with a company where I can make that happen by climbing there ladder. I also want to be with a company that makes me happy.

Tell me about some of your current sites:

Well I am working with mostly Fresenius sites in the Southeast, FL, TN, AL, SC. But I conducted multiple SIVs across the country as study need called for.

What would you do if you went to a site and your time was cut short? Or what would you do if you went to a site and the study coordinator told you she only had two hours to be on site, how would you prioritize your visit? Or what would you do if you went to a site and the SC was no where to be seen?

Well first I would check the delegation of authority log and see if there is a back up study coordinator some where. If there is I will see if she is available and work with her throughout my visit. If there is no one available I would go about my visit completing as much as I can and request for an additional day on site to compete anything I was unable to do that required the SC presence. If I went to a site and my time was cut short by any means- I would still check the DOA to see if there is a back up coordinator but if there isn't then I would prioritize my visit based on importance since I only have a short amount of time on site. First thing I would do after signing the site visit log will be to review the informed consent of all newly enrolled subjects. Then I would check to see if there have been any SAEs since the last monitoring visit and ensure they have all been reported properly. Then I would review for subject eligibility. If there is any more time after that I would go about my visit performing SDV, IP accountability, and review of the regulatory binder.

Tell me a little bit about the studies you are working on?

Well, I am working on a phase I-II study on Pruritis in the CKD population. Its an interesting study because there aren't really any drugs that address this particular issue. I have been on that study for 1 year now and I am working on 15 sites with that study.

What current metrics are you following:

Well, in regards to reports, the draft is due in five business days and the final is due in an additional five business days. Our follow-up letters are due in 10 business days. And expense reports are due in 30 business days.

Are you authorized to work in the country?

Yes

Are you willing to travel nationally or globally?

Yes

DO you have access to skype?

Yes

Do you have any experience in risked based monitoring?

Yes

Do you have experience with In patient studies subjects and outpatient?

Yes

Have you ever used EMR:

Yes electronic medical records.

Have you worked on an oncology study?

Yes mutiple

DO you receive any bonuses in addition to base salary?

Yes, I receive bonuses based off of my metrics.

Are you ok with national travel?

Yes, I understand as a CRA I do have to go outside of my region every now and then so I am okay with national travel.

How were you trained?

You were required to take self paced GCP/ICH and FDA regulation classes, after that they gave you an exam. After the exam, you went on observation visits for each of the type of site visits, After the observation visits, you went for Sign off (you were observed conducting the visit). After the process,

What document do the IRB approve prior to study startup:

confidentiality agreement, protocol, ICF template, sample CRFs, investigator brochure, budget and clinical trial agreement template, advertising materials and brochures, financial disclosure forms, 1572 template, study operations manual, and pharmacy manual.

What are the end points of the study:

safety and tolerability