Ich-GCP11.1recruitment and recruitment. Reserved (1)

Part 2: Recruitment

Part 3: Recruitment Strategy

The purpose of clinical research is to answer a research question. To do this, researchers must:

I. Recruit a sufficient number of suitable participants.

Ii. Keep these participants as much as possible within the time period specified in the research plan.

The purpose of clinical research is to answer a research question. To do this, researchers must:

1. Recruit a sufficient number of suitable participants.

2. Keep as many participants as possible within the time specified in the research plan.

Overoptimistic recruitment and retention predictions are common in clinical research. If there is insufficient recruitment or retention, the research may not achieve its goal. Researchers may not be able to answer their research questions, and participants recruited into the research may be in danger aimlessly. Therefore, recruiting and retaining participants is the key to the success of any clinical research.

In clinical research, over-optimistic recruitment and retention predictions are common. If there is not enough recruitment or retention, a research may not achieve its goal. Researchers may not be able to answer their research questions, and participants recruited into the research may be exposed to risks without any purpose. Therefore, recruiting and retaining participants is the key to the success of any clinical research.

A successful recruitment and retention strategy requires informed and detailed planning, commitment of sufficient resources, careful monitoring, and timely detection and resolution of problems.

A successful recruitment and retention strategy requires informed and detailed planning, commitment of sufficient resources, careful monitoring and timely detection and resolution of problems.

Recruitment and retention strategies, including the wording, presentation and dissemination of advertising materials, must be approved by the IRB before implementation.

Recruitment and retention strategies, including the wording, presentation and communication methods of advertising materials, must be approved by IRB before implementation.

Recruitment and retention are challenges that both clinicians and researchers need to spend a lot of time and energy. This module discusses the issues that need to be considered when recruiting and retaining research participants. Part 1 deals with recruitment and part 2 deals with retention.

Recruitment and retention is a challenge, which requires clinicians and researchers to spend a lot of time and energy. This unit discusses the issues that need to be considered when recruiting and retaining research participants. Part 1 deals with recruitment and part 2 deals with retention.

There are two main factors in studying recruitment:

I. Determine the appropriate groups of participants to answer research questions.

Ii. Recruit suitable participants in an ethical way.

There are two main factors in studying recruitment:

1. Identify appropriate participants to answer research questions.

2. Recruit suitable participants in an ethical way.

As described below, determining the subject population of clinical research needs to consider various issues.

Defining a participant group in a clinical study involves considering various issues, as described below.

The purpose of research is usually to determine the appropriate participants in the research. For example, the purpose of the study may be to test interventions for pregnant women with pregnancy-induced hypertension, runaway girls involved in the criminal justice system, veterans who use tobacco products or other specific groups.

The purpose of research is usually to determine the appropriate group of participants in the research. For example, the purpose of the study may be to test interventions for pregnant women with pregnancy-induced hypertension, runaway girls in the criminal justice system, veterans who use tobacco products or other identified population subgroups.

It is important that the findings of clinical research should be related to people who have not participated in the research but have the same characteristics as the research subjects. This is called generalization. The number of participants must be sufficient so that the results of the study can be applied to the general population who may benefit from the study.

Importantly, the results of clinical research are related to people who have not participated in the study but have the same characteristics as the participants in the study. This is called universality. The number of participants must be large enough so that the research results can be applied to the general population who may benefit from the research.

1979 Belmont report establishes three key principles on which the current human research protection system depends: respect for human beings, charity and justice.

The Belmont report of 1979 establishes three key principles on which the current research system for protecting human body is based: respect for individuals, charity and justice.

The principle of justice requires fair selection of participants. Researchers must always try to distribute the risks and benefits of participating in research fairly and without prejudice among the population.

The principle of fairness requires fair selection of participants. Researchers must strive to distribute the risks and benefits of participating in research fairly and without prejudice among the population.

When deciding to select some people for research and exclude others, researchers must ensure that the reasons for choosing participants are directly related to the problem being studied, not just because of their availability, their compromise position or their vulnerability.

When deciding to choose some people to participate in a study and exclude others, researchers must ensure that the reasons for choosing participants are directly related to the problem under study, not just because of their availability, their compromise position or their vulnerability.

Unless there is a clear reason to do so, the study should not involve people from groups that are unlikely to benefit from the subsequent application of the study. For example, it is immoral to choose only welfare recipients, institutionalized people or members of a particular race or ethnic group as research participants, unless the intervention under study is aimed at directly benefiting that group.

Unless there is a clear reason, the study should not involve groups that are unlikely to benefit from the subsequent application of the study. For example, it is immoral to select only those who live on welfare, those who are institutionalized or members of a certain race or ethnic group as research participants, unless the intervention to be studied is aimed at directly benefiting this group.

Women and ethnic minorities should be fully represented in the research population, so that the research results will be meaningful to these groups and the members of these groups can share the benefits of research. This is especially important for studying diseases, disorders and diseases that particularly affect women or ethnic minorities.

Women and ethnic minorities should be fully represented in the research population, so that the research results are meaningful to these groups and members of these groups can share the benefits of research. This is especially important for studying diseases, disorders and diseases that have a great impact on women or ethnic minorities.

Since 1994, researchers have been asked by the National Institutes of Health to provide a clear and convincing reason for suggesting that research should be conducted among people who are underrepresented in women and ethnic minorities. (See NIH's policy and guideline on the inclusion of women and ethnic minorities in clinical research subjects-revised 5438+0 in 2006 10. )

Since 1994, researchers have been asked by the National Institutes of Health to provide a clear and convincing reason to suggest that research should be conducted among people with insufficient representation of women and ethnic minorities. (See the policies and guidelines of the National Institutes of Health on the inclusion of women and ethnic minorities in clinical research-revised 5438+0 65438 in 2006 10).

Some groups of participants are considered to be more likely to be forced to participate in the study. Children, prisoners, economically disadvantaged groups or educationally disadvantaged groups are all regarded as vulnerable groups.

Some groups of participants are considered to be more likely to be forced to participate in the study. Children, prisoners, economically disadvantaged groups or educationally disadvantaged groups are all regarded as vulnerable groups.

Generally speaking, participants from disadvantaged groups should only take part in research directly related to their situation. For example, pregnant women should only participate in pregnancy research related to research questions (for example, to investigate whether one treatment strategy is more effective than another among pregnant drug abusers).

Generally speaking, participants from disadvantaged groups should only participate in research directly related to their environment. For example, pregnant women should only participate in pregnancy research related to research questions (for example, to investigate whether one treatment strategy is more effective than another for pregnant drug abusers)

When recruiting participants from vulnerable groups for research, the program must include appropriate additional safeguards to ensure that their rights and welfare are protected. (This issue is also discussed in the module of Informed Consent and Institutional Review Committee. )。 However, vulnerable groups should not be overprotected to avoid being excluded from the study.

When recruiting participants from vulnerable groups for research, the scheme must include appropriate additional safeguards to ensure that their rights and welfare are protected. (Informed Consent and Institutional Review Committee module also discussed this issue. However, vulnerable groups should not be overprotected and prevented from participating in the research.

The inclusion and exclusion criteria accurately define who is eligible to participate in the study and who is not. These standards must be defined in the research plan. Each potential participant must also be carefully examined.

Inclusion and exclusion criteria precisely define who is eligible to participate in the research and who is not. These standards must be defined in the research plan. Every potential participant must also be carefully examined.

I. Inclusion criteria are the characteristics that make potential participants eligible to participate in the study. Generally speaking, every potential participant must meet all the selection criteria to qualify.

Ⅱ. Exclusion criteria refer to the features that prohibit potential participants from joining the study. Generally speaking, if a potential participant meets one of the exclusion criteria, he or she will not be eligible.

The inclusion criteria of 1. are the characteristics that make potential participants eligible to participate in the study. Generally speaking, each potential participant must meet all the selection criteria to qualify.

2. Exclusion criteria refer to the characteristics that prohibit potential participants from participating in research. Generally speaking, if a potential participant meets one of the exclusion criteria, the participant is not eligible.

Inclusion and exclusion criteria must be reasonable and suitable for research purposes. Without justifiable reasons, no individual or group may be excluded from participating in this research. On the other hand, no individual or group should be included unless they may benefit from the application of research.

Inclusion and exclusion criteria must be reasonable and suitable for research purposes. No individual or group may be refused to participate in this research without justifiable reasons. On the other hand, no individual or group should be included unless they can benefit from the application of research.

Too strict inclusion and exclusion criteria may make it difficult to recruit enough participants to participate in the study. Modifying too strict research access standards can have a far-reaching positive impact on recruitment. On the other hand, too broad inclusion and exclusion criteria may make it more difficult to draw meaningful conclusions, and may also lead to an increase in security issues.

Too strict inclusion and exclusion criteria may make it difficult to recruit enough participants to participate in the study. Modifying a study's too strict admission criteria will have a far-reaching positive impact on recruitment. On the other hand, too broad inclusion and exclusion criteria may make it more difficult to draw meaningful conclusions, and may also lead to an increase in security issues.

A successful recruitment strategy includes the following elements:

Elements of a successful recruitment strategy include:

I. Avoid specifying unnecessary restrictive inclusion and exclusion criteria in the scheme.

Second, make a compensation strategy to fully compensate the participants for their time and expenses, but not too generous.

Iii. Make a recruitment plan in the scheme planning stage.

Ⅳ. There is a necessary recruitment budget for starting training, advertising, staff time and other expenses.

ⅴ. Establish the files of prospective research participants:

1. What will motivate potential customers to join the research?

Where did they get the information?

What radio and TV programs do they listen to and watch?

Where do they live, work, shop and play?

5. In what media is it appropriate to publish job advertisements?

Which caregivers and relatives can be used as referral sources?

ⅵ. Review the recruitment rate, withdrawal rate and screening success rate of previous studies. Identify and implement strategies based on past successes, and draw lessons from them.

Seven, choose the right employees for recruitment.

ⅷ. Develop a system to track the number of participants registered by each recruiter at each site.

Nine, carefully monitor the recruitment and intervene quickly to change the recruitment skills that have proved unsuccessful.

X. Identify recruitment barriers.

1. Avoid specifying unnecessary restrictive inclusion and exclusion criteria in the agreement.

2. Develop compensation strategies to fully compensate participants for their time and expenses, instead of demanding generosity.

3. Make a recruitment plan in the scheme planning stage.

4. There is a necessary recruitment budget for starting training, advertising, staff time and other expenses.

5. Establish the files of prospective study participants:

(1) What factors will prompt applicants to join this study?

(2) Where did they get the information?

(3) What radio stations, TV stations and programs do they listen to?

(4) Where do they live, work, shop and have fun?

(5) What media are job advertisements suitable for?

(6) Which caregivers and relatives can be used as referral sources?

6. Review the recruitment rate, dropout rate and screening success rate of previous studies. Determine and implement strategies based on past successful experiences and learn from them.

7. Select the right employees for recruitment.

8. Develop a system to track the number of participants of each recruiter on each website.

9. Carefully supervise the recruitment, and quickly intervene to change the recruitment techniques that have proved unsuccessful.

10, identify recruitment barriers.

Generally speaking, the recruitment strategy is the most effective when used in coordination.

Generally speaking, recruitment strategies are most effective when used in coordination.

First, contact interested potential customers as soon as possible. The longer a potential participant waits before receiving a reply from the researcher, the less likely he or she will eventually join the study.

Second, cultivate potential research recommendation sources and establish contact with clinic staff who are not involved in the research and other local health care providers. Send a direct mail to the selected health care provider.

Iii. Introduce the research to clinical staff and update the research progress regularly.

Ⅳ. Participate in health fairs, speeches, support groups, TV and radio interviews and other forums.

5. Require public service advertisements on radio and television.

1. Please contact interested customers as soon as possible. The longer a potential participant waits before receiving feedback from researchers, the less likely he or she will eventually join the study.

2. Cultivate the potential sources mentioned in the study and establish a network with clinic staff and other local medical service providers who did not participate in the study. Direct mail to selected health care providers.

3. Make research reports for clinical staff and update the research progress regularly.

4. Participate in health fairs, speeches, support groups, TV and radio interviews and other forums.

5. Request for public service announcements on radio and television.

Researchers who want to recruit alcohol or drug abusers to participate in clinical research must ensure that potential participants are not used.

Researchers who want to recruit alcohol or drug abusers to participate in clinical research must ensure that potential participants are not used.

The National Advisory Committee on Alcohol Abuse and Alcoholism issued a research guide involving participants in alcohol abuse. These guidelines also apply to studies involving participants who abuse drugs other than alcohol. Regarding the recruitment of participants who are addicted to alcohol or drugs, the guidelines stipulate that:

The National Advisory Committee on Alcohol Abuse and Alcoholism issued a research guide involving alcoholics. These guidelines also apply to studies involving participants who abuse drugs other than alcohol. Regarding the recruitment of participants who are addicted to alcohol or drugs, the guidelines stipulate that:

I. Alcohol or drug abusers should not be recruited as participants just because they are easy to obtain, have low social or economic status or have limited ability to understand the nature of research.

Ii. The suggested population of any study must be appropriate in terms of age, sex, family or genetic background, previous alcohol use, other drug use and general medical and psychological conditions, including the recovery status of alcoholism if appropriate.

1. Alcohol or drug abusers should not be recruited as participants just because they are easy to obtain, have low social or economic status or have limited ability to understand the nature of research.

2. The recommended population of any study must be appropriate in terms of age, gender, family or genetic background, previous drinking, use of other drugs, general medical and psychological status and (if necessary) rehabilitation of alcoholism.

Most research participants are recruited in the following three ways:

Most research participants were recruited in one of three ways:

I. Customers who have been treated in the research center are required to consider participating in appropriate research.

Ii. Other medical service providers will recommend potential research participants.

Iii. Individuals who are interested in participating in the research will respond to advertisements in newspapers or leaflets and advertisements on radio or television.

1. Customers receiving treatment in the research center need to consider participating in appropriate research.

2. Other medical service providers will recommend potential research participants.

Individuals who are interested in participating in the research will respond to advertisements in newspapers or leaflets and advertisements on radio or television.

Research can also use websites to recruit and screen participants. This method is especially useful when recruiting researchers related to socially awkward diseases or conditions.

Research can also use websites to recruit and screen participants. This method is particularly useful when recruiting researchers related to socially awkward diseases or conditions.

All recruitment strategies must be approved by the designated Institutional Review Board (IRB) before the research recruitment begins. In particular, when participants are recruited through advertisements, certain rules apply; These rules will be discussed in the next section.

Before recruiting researchers, all recruitment strategies must be approved by IRB. In particular, when recruiting participants through advertisements, certain rules apply; These rules will be discussed in the next section.