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National Hypothesis Generating Questionnaire

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Cyclosporiasis National Hypothesis Generating Questionnaire v 3.0 (January 2018)

State/NNDSS ID#:
Form Approved
OMB No. 0920-1198
Exp. Date 09/30/2020

General information (Questions to be completed by interviewer before the questionnaire is administered)

1. Classify case based on CDC case definition:

Laboratory information:

2. Date(s) stool collected for Cyclospora testing:

3. Test results:

4. Specify type of testing laboratories (Check all that apply including confirmatory lab):

5. Specify testing method(s) (Check all that apply including confirmatory test):


Other, specify:

6. Specify name(s) of lab-confirmed coinfection:

7. Additional information (e.g., patient has appointment to submit stool, lab accession number, etc):

Interviewer information:

8. Name:

9. Agency or organization:

10. Contact phone number:

11. Date of interview: (Required)

12. Before this interview, how many times has the case-patient been interviewed about his/her illness?

13. Respondent for the current interview was:

Begin interview

Hello, my name is [state interviewer name]. I am from INTERVIEWER HEALTH DEPARTMENT. We are contacting you because of your (your child's) recent infection with Cyclospora, which is a parasite that causes intestinal illness.

You may have already been contacted by someone at the health department, but I would like to ask you questions in a standard way about your (your child's) illness, and about any travel you may have had or foods you may have eaten before becoming ill.

Are you willing to participate in this investigation?

Public reporting of this collection of information is estimated to average 21 minutes per response...


Section 1: Demographic data

I'd like to begin by asking a few demographic questions.

1. State:   2. County:   3. Zip Code:

4. Date of birth:   5. Age:   6. Sex:

7. Do you consider yourself of Hispanic or Latino Origin?

8. How would you describe your race?
Other, specify:

Section 2: Clinical information

9. What date did you (your child) first feel sick?

Section 3: Travel, events, and ill contacts

10. Have you (your child) had any of the following symptoms?

  Date started:   Date stopped:






11. Have your (your child's) symptoms stopped?

12. Were you (your child) hospitalized overnight?

a. How many nights were you (your child) hospitalized?

b. Admission Date:

c. Hospital Name:

Section 4: Sources of produce at home

18. Did you (your child) eat foods from home sources? Please list store name, address, city, state, date shopped, food purchased, and shopper card number.

Store name Address City State Date shopped Food purchased Shopper card #

Refused to give shopper card #

Section 5: Sources of produce outside the home

19. Did you (your child) eat foods from restaurants or commercial food establishments?

Restaurant name Address City State Meal date Food eaten

Additional comments:

Section 6: Fresh herbs

20. Fresh basil?

Type(s):

Brand(s):

Place(s) purchased:

21. Fresh cilantro?

Additional comments about fresh herbs:

Section 7: Fresh berries and fruit

30. Fresh red raspberries?

31. Fresh blackberries?

32. Fresh black raspberries?

33. Fresh golden raspberries?

34. Fresh strawberries?

35. Fresh blueberries?

36. Fresh boysenberries?

37. Other fresh berries?

Additional comments about fresh fruit:

Section 8: Leafy greens

58. Pre-made, single serving salads?

59. Iceberg lettuce?

60. Romaine lettuce?

61. Mesclun lettuce?

62. Fresh cabbage?

63. Fresh spinach?

64. Other lettuce or leafy greens?

65. Other prepackaged salad mix?

Additional comments about leafy greens:

Section 9: Other fresh vegetables

66. Cucumbers?

67. Zucchini?

68. Squash?

69. Bell peppers?

70. Hot chili/chili peppers?

71. Celery?

72. “Mini” carrots?

73. Other fresh carrots?

74. Other raw root vegetables?

75. Fresh, raw peas?

76. Broccoli?

77. Cauliflower?

78. Sprouts?

79. Raw onions?

80. Raw green onions/scallions?

81. Fresh tomatoes?

82. Salsa or pico de gallo?

83. Fresh guacamole?

Additional comments, including other types of fresh vegetables:

This completes the interview. Thank you very much for your time. Would you like to provide any additional thoughts about anything we’ve discussed or about this outbreak investigation?

Enter text✕

What the National Hypothesis Generating Questionnaire Is

The National Hypothesis Generating Questionnaire is a standardized survey instrument designed to gather structured observations, exposures, and outcome signals across a wide population to inform initial research hypotheses. It combines demographic, behavioral, clinical, and environmental items into modular sections that can be adapted for epidemiologic, clinical, or social science studies. Responses are intended for exploratory analysis, not definitive causal inference, and the questionnaire includes metadata fields to document administration mode, consent status, and data provenance to support reproducibility and downstream statistical validation.

Why a Standardized National Instrument Matters

Use this questionnaire to systematically collect hypothesis-generating observations across populations, enabling consistent variable definitions, faster cross-cohort comparisons, and improved study reproducibility while preserving source context for later inferential analyses and validation workflows.

Why a Standardized National Instrument Matters

Primary Users and Typical Roles

Typical users span research teams, data managers, and program evaluators who need structured exploratory data collection.

  • Academic researchers conducting cross-sectional or longitudinal exploratory studies to identify novel associations.
  • Public health agencies monitoring emerging risk factors, syndromic signals, or population-level trends.
  • Clinical research networks piloting measurement items before including them in registries or trials.

Selection of respondents and administration mode should match study aims; document sampling frames and nonresponse to support interpretation.

Essential Components of a Professional Questionnaire

Core sections define scope, variable coding, consent, administration details, skip logic, and metadata to ensure consistent collection and compatibility with statistical workflows.

Scope

Describe the study population, objectives, inclusion and exclusion criteria, and the phenomena under investigation; clarity here prevents misinterpretation and supports correct analytic cohort construction across sites.

Variables

List each item with a precise variable name, response options, coding scheme, value labels, units, and permissible ranges to minimize harmonization work during pooled analysis.

Consent

Include standardized consent language, documentation of consent method, consent timestamps, and whether data may be reused or shared with third parties for secondary analysis purposes.

Administration

Specify administration mode (online, phone, in-person), instrument version, instructions to enumerators, expected duration, and accommodations for low-literacy or non-English respondents, including translated forms and assistive technologies.

Skip Logic

Document conditional pathways and dependent items explicitly; provide flowcharts or programmed logic tables to prevent missing data and ensure consistent branching across electronic platforms.

Metadata

Capture timestamps, device type, geolocation where permitted, administrator identifier, and form version to enable audit, linkage to other sources, and assessment of mode effects in analysis.

Step-by-Step: Completing the Questionnaire

Follow these steps to complete the questionnaire accurately and document administration metadata, including mode, enumerator ID, and timestamps.

  • 01
    Prepare: Confirm consent form and sampling frame before starting data collection.
  • 02
    Verify Identity: Confirm respondent eligibility and record identifier used.
  • 03
    Administer: Read items verbatim; record responses and any clarifications given.
  • 04
    Close: Confirm end timestamp, save draft, and upload to central repository.

Digital Administration Workflow at a Glance

Typical digital administration workflow for national-scale questionnaire deployments, from instrument setup to final data aggregation.

  • Design: Build items, branching, and validated response sets.
  • Pilot: Test on a small sample to refine wording and timing.
  • Deploy: Publish online, manage invitations, and monitor completion.
  • Aggregate: Export data, apply quality checks, and harmonize variables.

Key Configuration Settings Before Electronic Deployment

Settings to configure before electronic deployment to ensure consistent data capture and secure access across sites.

Field Configuration
Questionnaire Version v1.0; track changes in metadata
Auth Email or SSO; enable 2FA for sensitive data
Language Primary plus translated forms; set default locale
Auto-Save Enable drafts every five minutes to prevent data loss

Technical and Integration Requirements for Electronic Collection

Preferred distribution channels, file formats, and integration points to support scalable electronic collection and compliance monitoring.

  • Formats: PDF, DOCX, and CSV supported
  • Integrations: Connectors: NetSuite, Salesforce, Box, Google Workspace
  • Auth Options: Email link, SMS code, SSO, KBA

Security and Compliance Checklist

Encryption: TLS 1.2/1.3; AES-256 at rest
HIPAA: BAA available for covered entities
Audit Trail: Detailed timestamps, IP, user actions
Access Controls: Role-based permissions and SSO support
Data Residency: Flexible storage, EU-U.S. Data Privacy Framework
Authentication: Options: email, SMS, KBA, 2FA

Frequent Preparation Pitfalls to Avoid

  • Using ambiguous question wording that leads to varied interpretation across sites and undermines comparability during pooled analysis.
  • Failing to document version changes or skip-logic updates, which introduces unnoticed inconsistencies in datasets and complicates harmonization efforts.
  • Collecting unnecessary identifiers or sensitive data without clear justification increases privacy risk and may trigger HIPAA or state data breach laws.
  • Relying on open-text fields for key measures instead of coded responses complicates quantitative analysis and raises intercoder reliability issues.

Consequences of Incorrect or Incomplete Questionnaires

Misclassification: Biased results and invalid hypotheses
Nonresponse Bias: Reduced generalizability and power
Privacy Breach: HIPAA violation risk if PHI exposed
Invalid Consent: Legal challenges to data use
Missing Metadata: Precludes reproducible analysis
Regulatory Penalties: Fines and corrective action possible

Timing Considerations for Pilot, Fieldwork, and Reporting

Key timing considerations for administration, submission, and data processing across national studies, including pilot, fieldwork, and archive submission timelines.

Pilot Testing Window:

Allow two to four weeks for cognitive testing and revisions.

Main Field Period:

Typical national rollout spans four to twelve weeks depending on sampling complexity.

Reminder Schedule:

Send up to three reminders at one-week intervals to nonresponders.

Data Lock Deadline:

Set data lock two weeks after final collection for cleaning and harmonization.

Reporting Timeline:

Preliminary results within six to eight weeks; final dataset release after quality checks.

eSignature Vendor Comparison for Questionnaire Workflows

Side-by-side pricing and feature snapshot for common eSignature vendors. signNow is listed first in accordance with vendor data and plan differences.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day trial Varies Varies Varies Varies
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No cap 100 envelopes/user/year Varies Varies Varies

Frequently Asked Questions and Troubleshooting

Answers to frequent operational and legal questions about administering, validating, and legally relying on the National Hypothesis Generating Questionnaire.


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