Answer keys for Assignment 21: Preparing a concept paper for research project(The correct answer is underlined in bold text)

1. References need to be written following standard guidelines such as International Committee of Medical Journal Editors (ICMJE)

a. Trueb. False

2. Which of the following needs to be spelt out in “Expected benefits” section of the concept proposal?

a. Expected outputs that the study will generate with timelineb. Proposed immediate action based on research findingsc. How this research may set agenda for further researchd. All of the above

3. Budget estimate is not mandatory in the concept papers. However, it would be very useful to prepare an indicative budget

a. Trueb. False

4. Advantages of writing a concept paper includea. You may be able to organize your ideas b. It gives an opportunity to stand out and receive a positive response from reviewersc. You are sure to get fundingd. ‘a’ and ‘b’

5. The elements of the methods section in the concept proposal needs to be adapted according to the study design chosen

a. Trueb. False

6. The initial outline of the research protocol a. Concept paperb. Abstract c. Poster presentationd. All of the above

7. Which among the following is not a component of concept paper?a. Background and justification b. Objectives and Methods c. Expected benefits, Key references and Budgetd. Conclusion

8. The ethics section of the concept proposal should include information abouta. Key measures taken to protect the study participantsb. The ethics committee to which the study will be submitted for approvalc. Scientific committee that will review the studyd. ‘a’ and ‘b’

9. Which of the following is NOT true about references in the concept paper?a. We can cite references in Introduction and Methods section b. It is important to write references following standard guidelinesc. Statements should be linked to references d. We can have as many references as possible

10. While writing the concept papers for intervention studies, the methods section must have the following detailsa. Primary and secondary outcome definitionsb. Randomization, sequence allocation and allocation concealment c. Dose, frequency, nature of Interventiond. All of the above

Answer keys for Assignment 22: Elements of a protocol for research studies (The correct answer is underlined in bold text)

1. Inclusion and exclusion criteria should be included under the following section in the protocola. Sampling b. Study Populationc. Study designd. Sample size

2. The details regarding data quality assurance should be written in the following section in the protocola. Data collection b. Data analysisc. Project implementationd. Data entry

3. Study participants willingness to participate in the study is obtained bya. Informed consent b. Oral commitmentc. Willingness not necessaryd. None of the above

4. The paragraph which explains how the objectives lead to indicators a. Introductionb. Study design c. Budget d. Objectives

5. The following annexure in the study protocol deals with toxicity managementa. Study management formsb. Standard operating proceduresc. Consent formsd. Adverse event management form

6. Study population, sample size and sampling are included in the following section of the protocola. Introduction b. Methods c. Objectivesd. Expected Benefits

7. First step for writing a successful protocol a. Write a one page concept paperb. Identify topic, research question and objectivesc. Write a draft protocold. Seek ethics approval

8. Human participant protection paragraph addresses all excepta. Confidentialityb. Risksc. Compensationd. Sample size calculation

9. The initial outline of the protocol isa. Concept paperb. Abstractc. Poster presentationd. All of the above

10. Key outcomes and exposures should be explained under a. Data analysisb. Data Collection tools c. Samplingd. Operational definitions