Support Statement B - 0925-0602 - 22October2012[1]

Supporting Statement B for

Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research

Name: Robert Lembo, MD

Address: 10 Center Drive, Room: 1 N252C

Bethesda, MD 20892

Telephone: 301-496-2636

Fax: 301-435-5275

Email: robert.lembo@nih.gov

Table of contents

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS 1

B.1 Respondent Universe and Sampling Methods 1

B.2 Procedures for the Collection of Information

B.3 Methods to Maximize Response Rates and Deal with Non-response

B.4 Test of Procedures or Methods to be Undertaken

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting

and/or Analyzing Data

B.1 Respondent Universe and Sampling Methods

The sample is the entire cohort of trainees enrolled annually in education programs administered by the Office of Clinical Research Training and Medical Education (OCRTME). This cohort includes former clinical research trainees. This approach is justified by: 1) external accreditation mandates requiring that select participants be surveyed; and 2) the relatively low total number of participants, allowing for complete sampling across each of the OCRTME training programs. Because the cohort consists of doctoral level trainees, students, and other trainees, the annual sampling is done within each of these strata, as appropriate to the program. No logistical or statistical problems related to sampling resulted because of this approach and no specialized approach to sampling is required. No sampling intervals of less than one year duration are needed for program evaluation.

# of total entities (persons)	# in sample	Expected response rate for entity
Doctoral Level	708	50%
Students	538	75%
Other	40	66%

Expected response rate for collection as a whole:

Sixty-one (61)%

B.2 Procedures for the Collection of Information

The data collection method is a survey containing questions allowing dichotomous responses or categorical responses arranged on Likert scales. These questions are subjected to simple quantitative analysis (percentages, means, standard deviation). Some questions allow input of free text and are subjected to qualitative analysis.

The survey is administered and the information is collected on-line. An e-mail with a link to the survey is sent to participants. Non-participants are sent reminder e-mails. The survey software permits data analysis and summary reports. The Office of Clinical Research Training and Medical Education is responsible for this process. Quality control remains the responsibility of the software vendors (Advanced Informatics, LLC, Minneapolis, Minnesota, and SurveyMonkey, LLC, Palo Alto, CA).

B.3 Methods to Maximize Response Rates and Deal with Nonresponse

Non-responders are contacted by e-mail with reminders to complete the survey. These reminders are sent periodically. Non-responders are categorized as non-participants and are excluded from data analysis. The response rate for the survey includes all participants in the numerator and all eligible to participate in the denominator. Quantitative analysis of individual questions in the survey is based on actual respondents, not potential respondents.

B.4 Test of Procedures or Methods to be Undertaken

No additional testing is proposed or planned for this survey.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Robert Lembo, MD, Office of Clinical Research Training and Medical Education, NIH Clinical Center, NIH. 301-496-2636.

Advanced Informatics, LLC, 10 Second Street NE, STE 300, Minneapolis, MN 55413 612‐253‐0130.

SurveyMonkey.com, LLC, 285 Hamilton Avenue, Suite 500, Palo Alto, CA 94301

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