Look for the answer to your questions in our FAQ

Investigator Site Registration Questions

What special laws or regulations do I need to be aware of when conducting medical research?

A. There are a number of laws and regulations governing medical research. We suggest you review the following links for more information:

• FDA’s Center for Drug Evaluation and Research (CDER)
• Federal Regulations for Clinical Investigators and guidance documents
• Good Clinical Practice: Consolidated Guideline and guidance documents

What are the benefits of participating in medical research with PMI?

A. Participating in medical research studies can be a rewarding experience. For instance, as an active study site, you are taking a role in the advancement of medical science. You’ll also have an opportunity to learn about new therapies before they are introduced. And, you may benefit from a new revenue source for your practice.At PMI, we strive to make your participation in medical research a positive process from start-up through to study closeout. Study initiation visits generally include the training you need to set your study up for success. A PMI project manager carefully oversees the study timeline, budget and tasks, and our Clinical Research Associate (CRA) visits your site regularly to monitor the study’s progress and assist you whenever needed. We also engage in ongoing, open communication with access to your PMI project manager or client representative.

What kind of time commitment should I expect as an investigator?

A. Every study is different, so it is hard to generalize. However, when working with PMI, you may expect to attend a 1-2 day investigator meeting to be trained on the study protocol. These meetings generally last about two days. (Travel expenses are usually covered by the sponsor.) Alternately, and based on sponsor preference your training may occur through interactive web-based programs, or on-site visits.During the study, your site may be visited by representatives of the sponsor and will be visited by PMI. The purpose of these visits is to review documentation and to confirm that the study is being conducted properly. At PMI, these representatives are called Clinical Research Associates (CRAs). You and your study coordinator should expect to spend a fair amount of time with the CRA during each visit.

For more information regarding your time commitment as an investigator, go to: Association of Clinical Research Professionals (ACRP).

Who else can be involved in the studies in which I participate?

A. Other physicians in your practice may participate as sub-investigators as long as the sponsor approves and the appropriate regulatory documentation is submitted before their involvement begins.

What are the qualifications of a study coordinator?

A. At PMI, we prefer that study coordinators have experience with clinical research, including patient care, data reporting, paperwork, etc. Ideally, your study coordinator should be accredited. See our tutorial course or ACRP.

Are there any regulations governing electronic submissions from a study site?

A. Yes. Click here to 21 CRF Part II to review the provisions set forth by the FDA regarding electronic submission.

Is it appropriate to bill a patient’s insurance company for the work I do while the patient is on the study?

A. No, you should never bill a patient’s insurance company for any work you do with that patient that is related to the study. This practice constitutes insurance fraud.

Sponsors generally have a predetermined amount that they pay per patient for each procedure or patient visit. This information can be found in your study financial agreement.

What costs should I consider in budgeting for a study?

A. Every study is different, but we can provide some general guidelines. First, determine how many patients you feel you can enroll based on the study inclusion/exclusion criteria. (Consider also how many patients you may have to screen to achieve that number.) Next, from the protocol determine what procedures are required for each patient. Assign a cost to each procedure, and apply the results to the number of patients you expect to enroll. Be sure to take into account the number of hours per staff member you need to run the study effectively, as well as any overhead costs.

What technology do I need?

A. A computer and fax machine is needed. A fast speed internet connection will give more efficiency with your coordinator time on electronic-web based studies (EDC). Reviewing regulations for 21 CFR Part II and electronic signature guidelines for your system compliance is important.

Can I publish findings or results from a study in which I participate?

A. The terms under which you are allowed to publish will be in your study contract. Generally speaking, however, sponsors reserve the right to make the first publication of study results.

Investigator and Coordinator GCP Education Tutorial Questions

How do I register to take the course?

Please send your registration request by e-mail with the online registration form. Upon receipt at PMI, we will forward a return e-mail with payment processing information. Once PMI receives your payment, you will be sent an e-mail notifying you of course registration, along with your assigned user name and password for course access.

To facilitate receipt of program-related messages, please remember to adjust your spam filter to allow messages from system@traincaster.com.

The tutorial has multiple modules – can I complete these modules in any order I wish?

Each module is followed by a quiz to reinforce key points and allow you to assess your knowledge retention. Modules must be reviewed sequentially and the associated quiz completed prior to moving to the next module.

How long will it take me to complete each module?

Dependent on your Internet connection speed, prerequisite knowledge, etc., each module can be completed within 20 – 45 minutes. Remember, however, you can stop work at any point during a module and return later to resume where you left off!

How long do I have to complete the tutorial before my registration expires?

Once registered, you may log on to review coursework materials an unlimited number of times over a 60-day period, resuming where you leave off. You will be reminded via e-mail well in advance of your registration’s expiration.

Again, to facilitate receipt of program-related messages, please remember to adjust your spam filter to allow messages from system@traincaster.com.

After I complete the program, can I go back and review the contents?

You may review the course contents any time within 60 days of initial registration by clicking on the “My Traincaster” tab, then on the “Course Resources” folder. After opening the “Course Resources” folder, click on the “Take Course for No Credit” button.

Your quiz scores may also be reviewed from the “My Traincaster” tab. To do this, go to the “My Menu” pulldown and select “My Course History”. In the table presented, click on data contained in the “Score” section to see your test results by module.

Can I print out the program if I want?

You can print the course content by clicking on the “My Traincaster” tab, then on the “Course Resources” folder. After opening the “Course Resources” folder, click on the “Print” button.

How do I access documents in the Course Repository?

The Course Repository contains documents referenced in the “Guidance & References” slides in the tutorial. You can access these documents by clicking on the “My Traincaster” tab, then on the “Course Resources” folder. After opening the “Course Resources” folder, click on the “Course Repository” button.

Can I print documents from the Course Repository?

You may view or download documents contained in the Course Repository by clicking on the “My Traincaster” tab, then on the “Course Resources” folder. After opening the “Course Resources” folder, click on the “Course Repository” button and select the document(s) you wish to view or download.

For the quizzes, what is a “passing” score?

A passing score is 100%.

Do I have to achieve a 100% score on each quiz in order to continue to the next module in the tutorial?

The quizzes are set up to provide guidance regarding the correct answer in the event your selection was incorrect. You must answer each quiz question correctly before you can proceed to the next module.

Is there a limit on the number of times I can take the quiz?

The quiz may be taken repeatedly until all questions are correctly answered.

If I answer a question incorrectly, how can I get help to understand what the correct answer is?

The quizzes are set up to provide guidance regarding the correct answer in the event your selection was incorrect. In some cases, the system notes reference slide(s) that that also contain the correct answer.