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

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.

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).

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.

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.

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

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.

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.

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.

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.

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.

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.

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!

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.

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.

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.

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.

A passing score is 100%.

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.

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

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.

Eligible persons completing the Coordinator Tutorial will receive 4.5 hours credit. Eligible persons completing the Investigator Tutorial will receive 2.5 hours credit.

Please note – at the conclusion of the last training module, you must click on the hyperlink provided and complete the questionnaire to receive CME/CEU credits.

Accreditation will be issued by Promedica International CME, accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Promedica International CME is also accredited by the California Board of Registered Nursing to provide continuing education credit for nurses.

Your certificate will be sent to you via standard mail shortly after receipt of notification that you have completed the course.

The certificate provided on-line after completion of the last tutorial module is simply a certificate of completion – it is NOT your accreditation certificate! This certificate of completion is provided for those trainees who may be ineligible for receipt of CME/CEU credits.

Customized reports can be generated to show which users have registered, those who have or have not logged onto the system, and those who have completed training during a specified timeframe. The system can also be set-up to provide an automatic email notification to you when a trainee completes the tutorial.

To set-up this option, please indicate your need at the time of tutorial registration. The program administrator will contact you to discuss desired report(s).