A questionnaire is a tool used to systematically gather information from study participants. It should include questions to confirm eligibility criteria and categorize participants. Questions can be open-ended, allowing free responses, or close-ended, restricting answers to predetermined options. The order, wording, and formatting of questions must be carefully considered to obtain valid and understandable responses. Pilot testing with volunteers is essential to revise and improve the questionnaire.
Paxil Study 329 Retracted: A Critical Statistical AnalysisCarlo Carandang
I give a lecture regarding the statistical methodology employed in the 2001 Paxil (paroxetine) Study 329: Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, McCafferty JP. J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7):762-72.
Paxil Study 329 Retracted: A Critical Statistical AnalysisCarlo Carandang
I give a lecture regarding the statistical methodology employed in the 2001 Paxil (paroxetine) Study 329: Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, McCafferty JP. J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7):762-72.
From my writing course, a set of four moves that underpin many journal articles in the social sciences and humanities. Accompanies a blog post on patthomson.net
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Questionnaire Design - Meaning, Types, Layout and Process of Designing Questi...Sundar B N
This ppt covers Questionnaire Design - Meaning, Types, Layout and Process of Designing Questionnaire which includes Questionnaire Definition
OBJECTIVES OF QUESTIONNAIRE
Questionnaire design process
Guidelines for Question Wording
Increasing the willingness of respondents
Overcoming unwillingness to answer
Layout of the Questionnaire
Principles of data collection include principles, types, sources, and methods of data collection, which will help medical students to make their tools for data collection.
Clinical Research Statistics for Non-StatisticiansBrook White, PMP
Through real-world examples, this presentation teaches strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions.
From my writing course, a set of four moves that underpin many journal articles in the social sciences and humanities. Accompanies a blog post on patthomson.net
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Questionnaire Design - Meaning, Types, Layout and Process of Designing Questi...Sundar B N
This ppt covers Questionnaire Design - Meaning, Types, Layout and Process of Designing Questionnaire which includes Questionnaire Definition
OBJECTIVES OF QUESTIONNAIRE
Questionnaire design process
Guidelines for Question Wording
Increasing the willingness of respondents
Overcoming unwillingness to answer
Layout of the Questionnaire
Principles of data collection include principles, types, sources, and methods of data collection, which will help medical students to make their tools for data collection.
Clinical Research Statistics for Non-StatisticiansBrook White, PMP
Through real-world examples, this presentation teaches strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions.
A questionnaire is a research instrument consisting of a series of questions and other prompts for the purpose of gathering information from respondents.
Tools and techniques for data collection.pptxJuruJackline
These the tools and techniques used for data collection when carrying out community diagnosis in public health setting.
The slides looked into details the various tools and how they can be used in the data collection depending on the type of data you would like to collect.
Questionnaires is one of the most popular tool of collecting data
They provide a convenient way to gathering information from a target population. A questionnaire is a planned self-reported form designed to elicit information though written or verbal responses of the subjects.
Questionnaire is a research instrument consisting a set of predetermined questions to collect data from the respondents about one or more specific topics that serves as a primary research instrument in survey research
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
3. Overview
A questionnaire is a tool for systematically gathering
information from study participants.
Questionnaires can be designed for self-reporting or as
scripts for interviews.
5. Questionnaire Content
It is often helpful to start with a list of the main
categories of questions to be asked, and then to add
detail about the specific topics to be covered.
6. Questionnaire Content
• The questionnaire must include questions confirming
that participants meet the eligibility criteria for the
study.
• The questionnaire must also be able to accurately
place participants into key categories, such
confirming that all cases in a case-control study meet
the case definition.
• A survey should be neither too short nor too long.
7. Types of Questions
After determining the broad categories of questions and
the specific topics to be addressed in each section, each
question topic should be assigned a specific type of
question.
•Close-ended questions allow a limited number of
possible answers
•Open-ended questions allow participants to give free-
response answers
8. Open-Ended Questions
Open-ended questions allow participants to:
•explain their selections and qualify their responses
•give multiple answers
•provide responses not anticipated by the researcher
However:
•they take longer to ask and answer
•they may result in irrelevant answers
•recoding for statistical analysis is often difficult
9. Close-Ended Questions
Close-ended questions come in a variety of formats,
including:
•Date and time variables
•Numeric variables
•Categorical variables
•Paired-comparison variables
•Rank-order variables
10. Close-Ended Questions
Categorical variables come in a variety of formats:
•Dichotomous variables have only two response options
(like yes/no)
•Ordinal variables are ranked based on an inherent
order
•Nominal variables are have no built-in order
12. Anonymity
• Many questions can be asked in more than one valid
way, and the researcher must decide which question
type is most appropriate and will best protect
participants’ anonymity.
• If a name, an address, a birthdate, or other
information could link a participant to the study, then
there must be a solid plan in place for protecting the
privacy of participants and the confidentiality of the
information they share.
13. Types of Responses
Once the types of questions have been selected, a
decision must be made about the kinds of responses that
are appropriate for the question.
14. Types of Responses
• For numeric responses, the question should state
exactly how specific the answers should be.
• For categorical questions, consider all possible
responses for each question, and include as many as
needed (including, perhaps, “other” and “I do not
know”).
• For ranked questions, decide how many entries to
include on the scale and whether there will be a
neutral option.
16. Wording of Questions
After drafting the questionnaire, check each question for
clarity:
•Does each question ask what it is intended to ask?
•Is the language of each question clear and neutral?
•Will members of the study population understand the
language?
•Is the question sensitive to potential cultural issues
related to language?
17. Wording of Questions
Check to be sure that the responses are carefully
worded:
•Is the choice of response clear?
•For scaled questions, is the rank order clear? (For
example, is it clear that 1 is “strongly disagree” and 5 is
“strongly agree”?)
•For questions with unranked categories, is the order of
possible responses alphabetical or otherwise neutral?
19. Order of Questions
• Many questionnaires start with easy or at least
general questions before moving to more difficult or
sensitive questions.
• The questions should be in an order that flow
naturally from one topic to another, and similar
questions should be grouped.
• Think carefully about how previous questions could
taint the answers to later ones.
20. Layout and Formatting
The layout of the survey instrument will vary depending
on the mechanism of data collection used.
•A self-report survey, either paper-based or computer-
based, may require instructions about how to indicate
answers.
•For an oral survey, the interview script requires an
opening statement, transitions between sections of the
survey, closing sentences, spaces for recording
responses to questions, and other instructions.
23. Validation
A valid questionnaire measures what it was intended to
measure in the population being assessed.
•One way to seek validity is to include survey questions
or modules that are identical to the ones used in
previous research projects, but access to survey
questions is often not possible in the health sciences.
•Pilot testing of the new questionnaire is essential for
the development of a valid and useful tool.
24. Commercial Research Tools
A number of widely used and validated tests, primarily
from the social sciences, are available to researchers as
commercial products.
•Some of these tools are free of charge, but most require
payment for use.
•Some tests provide the instrument for free but require
researchers to pay to have the results scored and
validated against previous users of the survey
instrument.
25. Translation
Translation of the survey instrument into one or more
additional languages may be necessary.
•Check to be sure that the translated version expresses
the same meaning as the original survey.
•Accuracy may require the rephrasing of whole
sentences, not just direct word-for-word translations.
26. Pilot Testing
A pilot test (pretest) of the questionnaire is helpful for
checking content, clarity, layout, timing, and other
factors.
•Volunteers from the target population (but not the
sample population) should be asked to complete the
preliminary survey and provide feedback on it.
•The survey instrument should be revised based on
these observations.
•Several rounds of pilot testing may be required.