PASE Generic SS Part B 2017

U.S. Food & Drug Administration
Data To Support Social and Behavioral Research
as Used by FDA
OMB Control No. 0910-NEW
SUPPORTING STATEMENT—Part B: Statistical Methods

1. Respondent Universe
Study participants will include members of the general public and stakeholders with an interest
in or experience with drug products. These may include patients who take medications,
pharmacists, physicians, or other health care providers. Inclusion and exclusion criteria will vary
depending on the research topic. To identify potential variation according to regional
differences, information collections may be conducted at multiple sites in the United States when
appropriate.
The study samples will be selected from an appropriate demographic, including members of
online community groups, or samples obtained through in-person intercepts or mailings (e.g., in
health care facilities, community centers). Sampled respondents will be invited to participate in
the information collection through a various number of methods, such as: email, letters, in and
in-person interviews. Respondents who choose to participate will complete a screener
questionnaire and, if eligible, participate in the study. Studies will be monitored to ensure
samples are diversely representative in terms of age, gender, education, and ethnicity/race. Other
sources of samples may also be employed. Recommended methodologies and sample sizes will
be based on a review of the relevant literature, consultation with experts in the field, and
previous studies, regardless of source.
In qualitative studies, quota sampling is often used to select a convenience sample of individuals
who meet certain criteria that reflect characteristics typical of the demographic. Response rate is
not applicable to quota sampling because this type of sampling results in a nonprobability sample
not representative of the population. In qualitative studies, respondents are initially contacted by
telephone or by mail; where over-recruiting is done to compensate for non-responsive followups.
Where quantitative methods are used, information collection activities will target the particular
demographic with statistical sampling procedures employed to identify potential respondents.
Mail, telephone, and internet surveys typically will seek a sample that has a reasonable diversity
in key demographic characteristics such as age, gender, education, and race/ethnicity.

2. Procedures for Information Collection
Qualitative data collection will consist of interview, small group, and focus group
methodologies, i.e., qualitative methods. In qualitative studies, an individual or small group of
people engage in a discussion on selected topics of interest typically directed by a
moderator/interviewer who guides the discussion in order to obtain the person or group’s
opinions, perceptions, behaviors, or attitudes. Interviews and focus groups capture the insights
of an individual, or the collective insight of a group while preserving individual preferences. In
groups, participants can describe their experiences and preferences without the limitations of
preset response categories determined by investigators. Furthermore, interviews and focus
groups produce rich data complete with nuances that often may be obscured in quantitative data
collection techniques. The methods are used to produce qualitative data to help develop and
design educational interventions or communications, and interpret quantitative results obtained
from surveys or experiments.
Since interviews and focus groups are qualitative research methodologies, statistical methods
will not be employed to analyze interview or focus group data, as it is not appropriate to report
the percentage of focus group participants who expressed a particular view. Typically, not every
participant in a group comments on every issue discussed, and the course of discussion will vary
across groups, with some topics emerging in one group and not in another. Instead, descriptors
such as “many,” “several,” and “few” may be used to qualitatively describe the relative number
of participants or groups who expressed a particular view.
For most quantitative studies submitted under this generic clearance, FDA will use surveys,
either through internet-based surveys, phone surveys, in-person surveys, or mailed surveys.
When participants are recruited for survey participation the vendor will send invitations to the
target audiences. Each invitation will contain the title, an explanation of the research being
conducted, the expected length of the participation, any incentive amount that may be provided
for successful completion of the survey, and how an individual’s data will be kept confidential.
3. Methods to Maximize Response Rates
Participants will be recruited from sources offering the greatest likelihood of reaching the target
demographic. In the past, participants have been recruited from commercial databases or
through convenience sampling procedures. To minimize the possibility of having too few
appropriate participants (thereby forcing group cancellation) or too few interview/survey
participants, more participants may be invited than will be used. In the event that too many
participants report, excess participants will be dismissed. For quantitative methods, FDA will
implement several procedures to increase participation wherever possible. We will conduct
cognitive interviews and pretests to help improve understandability of the questionnaire, to
reduce participant burden, and to enhance administration. We will keep the questionnaire at a
reasonable length to minimize break-offs. Tested recruitment and data collection procedures will
be used to maximize cooperation and to achieve the desired response rates.

2

4. Tests of Procedures or Methods to be Undertaken
Pretesting of interview and focus group protocols to be used in these qualitative studies may be
done with internal staff or a limited number of external individuals. If the number of pretest
respondents exceeds nine members of the public, the agency will submit the pretest focus group
protocol for review under this generic clearance.
Before each information collection is implemented, a pilot test the collection/survey
instrument(s) and method of data collection will be conducted when possible. Lessons from the
pilot test will be identified, and changes, as necessary, will be incorporated accordingly. All
pilot tests will involve no more than nine individuals unless OMB clearance is sought for more
than nine.
FDA may conduct cognitive interviews to evaluate and refine a draft questionnaire or other study
materials. If the number of cognitive interview respondents exceeds nine members of the public,
the agency will submit the cognitive interview protocol for review. The cognitive interviews
will help identify areas where the collection/survey instrument was ambiguous, burdensome, or
confusing for respondents, and the survey or other study materials will be revised accordingly.
Additionally, FDA may conduct a pretest with individuals to thoroughly test the programmed
questionnaire. At the conclusion of the pretest, all strategies, algorithms, and programs for
sampling, survey administration, and data compilation will be tested, validated, and readied for
launch of the data collection instrument. The collection instrument will be revised based on the
pretest findings.
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing
Data
FDA primary investigators, staff, and contractors will be responsible for developing study
materials, including the moderator guides and screening criteria, with advice, if needed, from
data collection contractors. Sometimes, contractors may compile top line findings in the final
report if necessary.

3