標(biāo)題: Titlebook: Developing a Successful Clinical Research Program; Cara East Book 2018 Springer International Publishing AG, part of Springer Nature 2018 [打印本頁(yè)] 作者: mandatory 時(shí)間: 2025-3-21 16:56
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書目名稱Developing a Successful Clinical Research Program讀者反饋學(xué)科排名
作者: 熱烈的歡迎 時(shí)間: 2025-3-21 21:01
Book 2018present in American clinical research is the primary goal ofthis book. The second goal is to improve the understanding and education of those whoenter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a resear作者: hazard 時(shí)間: 2025-3-22 04:25 作者: ODIUM 時(shí)間: 2025-3-22 07:35
Choosing a Study,e most promising medications/devices/procedures. The second most important consideration will be to choose studies for which the team can recruit well. The talents and opportunities for the team and institution must then be evaluated. Finally, the studies to be chosen should expand team horizons and have the potential to change the world.作者: Dri727 時(shí)間: 2025-3-22 09:28 作者: savage 時(shí)間: 2025-3-22 15:41 作者: savage 時(shí)間: 2025-3-22 17:04 作者: 詞根詞綴法 時(shí)間: 2025-3-22 23:16 作者: 脖子 時(shí)間: 2025-3-23 01:34 作者: Forehead-Lift 時(shí)間: 2025-3-23 05:34
https://doi.org/10.1007/978-1-349-22936-9d at the expense of individual well-being and autonomy. The Nuremberg Code was developed in 1949 after the atrocities of Nazi medical research were discovered to codify the protection of human subjects and ensure voluntary consent. After the US Tuskegee Syphilis experiment came to light, the Belmont作者: bioavailability 時(shí)間: 2025-3-23 09:58
Jean Blondel,Ferdinand Müller-Rommele most promising medications/devices/procedures. The second most important consideration will be to choose studies for which the team can recruit well. The talents and opportunities for the team and institution must then be evaluated. Finally, the studies to be chosen should expand team horizons and作者: 交響樂(lè) 時(shí)間: 2025-3-23 15:56
Evaluating Cabinet Decision-Makingo add individuals with a medical background, but clinical research is more detail-oriented and team members must be comfortable that a placebo, inactive device, or sham procedure is being used. Processes are lengthy, and the best staff are those who are good at different tasks. Start-up procedures i作者: PANT 時(shí)間: 2025-3-23 20:58
Jean Blondel,Ferdinand Müller-Rommel. Then for the specific study, an estimate of how many months the study will take and what percentage of the team’s time will be attributed to it should be developed. This provides a rough guess but can be used together with the science of the study and the contract to decide if participation in the作者: enlist 時(shí)間: 2025-3-23 23:31 作者: CURT 時(shí)間: 2025-3-24 02:41
https://doi.org/10.1057/978-1-349-95109-3hould ask questions at any time. Research participants should be referred to as “subjects” to emphasize that they may not receive direct benefit from participating in the trial. More time should be spent on the consent process that on almost any other procedure in the trial. “If you take a medicine,作者: Kidnap 時(shí)間: 2025-3-24 06:36
https://doi.org/10.1057/978-1-349-95109-3review the study procedures. The team members should have already read the protocol, consent, and prescreening form. Then, immediately before the first subject is enrolled, the team should have a mock subject drill. After enrolling the first subject, a Study Update Meeting should be scheduled to deb作者: intellect 時(shí)間: 2025-3-24 12:26
The Governing Properties of Numbersluding randomized controlled trials (or RCTs), retrospective review of data that has already been collected, and prospective registries, which is an observational only trial. Some clinical research endeavors may be exempt from IRB review, some studies able to undergo expedited review, but must will 作者: anaerobic 時(shí)間: 2025-3-24 16:17 作者: 不可侵犯 時(shí)間: 2025-3-24 21:21 作者: Benzodiazepines 時(shí)間: 2025-3-25 02:45 作者: adduction 時(shí)間: 2025-3-25 04:15
The Governing Properties of Numbershe subject should also be told what to expect at the visit. Demographic information should be updated at every visit, as subjects regularly change cell phone numbers. Any new consents should be signed at the beginning of the visit, study medication should be collected and re-dispensed, and equipment作者: MEAN 時(shí)間: 2025-3-25 10:51 作者: Crepitus 時(shí)間: 2025-3-25 11:39 作者: 名詞 時(shí)間: 2025-3-25 18:23
Environmental Justice and Global Democracyhat serve the various research needs of pharmaceutical sponsors. The pharmaceutical industry invests as much as five times as much as the average manufacturing company does in research and development. CROs allow the industry to outsource many of the steps of the clinical research process. The CRO i作者: 偏離 時(shí)間: 2025-3-25 23:26
Evolving Tensions in Public Governanceicity should be reviewed. It is important to recognize if there has been any disproportionate recruiting of subgroups. Special attention should be given to any vulnerable or disadvantaged subjects who were enrolled. Issues with obtaining informed consent should be rigorously reviewed and any correct作者: ANT 時(shí)間: 2025-3-26 01:40
Incomplete Contracting and Policy Influencen their visit windows, collecting all study-related materials and updating all contact information. Effort must be expended to complete all study queries, and financial conflict of interest reporting must be repeated. All financial billing must be completed and received before the study can be forma作者: 輪流 時(shí)間: 2025-3-26 07:02
Designing the Administrative Stateicts of interest, specific research protocols, and medical areas of concentration. Professional organizations provide national meetings and certification exams for research staff, including certifications for CCRC, CCRA, CPI, ACRP-CP, and CCCP certifications. Financial incentives, including payment 作者: Initial 時(shí)間: 2025-3-26 12:26
Why Do Clinical Research?, tested in a sample representative of the entire population, including children and the elderly, both genders, all races and ethnicities, in patients with concomitant illnesses and medications, and those living in urban and rural environments. Reasons to participate in clinical research include enro作者: 閑逛 時(shí)間: 2025-3-26 13:50
How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect,d at the expense of individual well-being and autonomy. The Nuremberg Code was developed in 1949 after the atrocities of Nazi medical research were discovered to codify the protection of human subjects and ensure voluntary consent. After the US Tuskegee Syphilis experiment came to light, the Belmont作者: Expiration 時(shí)間: 2025-3-26 20:02 作者: Temporal-Lobe 時(shí)間: 2025-3-26 22:07 作者: 寬容 時(shí)間: 2025-3-27 03:26
Developing a Budget,. Then for the specific study, an estimate of how many months the study will take and what percentage of the team’s time will be attributed to it should be developed. This provides a rough guess but can be used together with the science of the study and the contract to decide if participation in the作者: Tailor 時(shí)間: 2025-3-27 08:15
Negotiating a Contract,ite, and/or the institution for the conduct of the clinical research trial. Responsibilities of the site include maintaining staff certifications and documentation, agreeing to follow the details of the protocol, obtaining appropriate subject consent, and providing all needed documents to the instit作者: STALE 時(shí)間: 2025-3-27 11:17
Writing a Great Consent,hould ask questions at any time. Research participants should be referred to as “subjects” to emphasize that they may not receive direct benefit from participating in the trial. More time should be spent on the consent process that on almost any other procedure in the trial. “If you take a medicine,作者: 充足 時(shí)間: 2025-3-27 14:28
Starting the Study,review the study procedures. The team members should have already read the protocol, consent, and prescreening form. Then, immediately before the first subject is enrolled, the team should have a mock subject drill. After enrolling the first subject, a Study Update Meeting should be scheduled to deb作者: 發(fā)起 時(shí)間: 2025-3-27 20:54 作者: Overstate 時(shí)間: 2025-3-28 00:20
Recruiting,ng that start-up costs are the same regardless of which goal is met. Flyers for medical facilities have a modicum of success as do giving presentations at medical speaking events, booths at health fairs or senior centers, or discussions at medical staff in-services. Referral letters to physicians ca作者: Intact 時(shí)間: 2025-3-28 05:19 作者: FEIGN 時(shí)間: 2025-3-28 09:04
The Screening Visit,be collected. For future follow-up, all phone numbers, email addresses, names of four friends and family members, and names and contact information for physicians should be listed. A picture of the subject (which may be on a driver’s license) and a medical release form should be completed. The medic作者: RAFF 時(shí)間: 2025-3-28 10:34 作者: avulsion 時(shí)間: 2025-3-28 17:39
Maintaining Subject Retention and Avoiding Study Fatigue,t all. There are multiple methods to impute missing data, but none are as good as having retained the subject in follow-up. The site can use many methods to maintain subject retention, including providing a stipend for visits, providing transportation or travel assistance, and having great staff. Ha作者: 現(xiàn)實(shí) 時(shí)間: 2025-3-28 20:31
Adverse Events and Protocol Deviations,involved in a research procedure. A serious adverse event is one that results in death, is life-threatening, requires hospitalization, results in a persistent or significant disability or incapacity, and results in a congenital anomaly or birth defect, or other serious conditions, such as a new canc作者: Benign 時(shí)間: 2025-3-29 00:51
Contract Research Organizations and Monitors,hat serve the various research needs of pharmaceutical sponsors. The pharmaceutical industry invests as much as five times as much as the average manufacturing company does in research and development. CROs allow the industry to outsource many of the steps of the clinical research process. The CRO i作者: Leaven 時(shí)間: 2025-3-29 06:06 作者: Medicaid 時(shí)間: 2025-3-29 07:18 作者: MEAN 時(shí)間: 2025-3-29 11:22 作者: Gustatory 時(shí)間: 2025-3-29 16:28 作者: visual-cortex 時(shí)間: 2025-3-29 22:40 作者: inundate 時(shí)間: 2025-3-30 02:59
Evaluating Cabinet Decision-Makingve device, or sham procedure is being used. Processes are lengthy, and the best staff are those who are good at different tasks. Start-up procedures include executing a clinical disclosure agreement (CDA), negotiating a contract, developing a budget, and writing a good consent.作者: Recess 時(shí)間: 2025-3-30 05:19
https://doi.org/10.1057/978-1-349-95109-3participating in the trial. More time should be spent on the consent process that on almost any other procedure in the trial. “If you take a medicine, thank a research subject.” A great consent most successfully makes the subject into a research partner.作者: 熟練 時(shí)間: 2025-3-30 08:21
https://doi.org/10.1057/978-1-349-95109-3t subject is enrolled, the team should have a mock subject drill. After enrolling the first subject, a Study Update Meeting should be scheduled to debrief the initiation steps of the study completed so far. Finally, it is important to insist on having the first monitor visit early so that misunderstandings can be corrected.作者: 夾克怕包裹 時(shí)間: 2025-3-30 12:48 作者: Medicaid 時(shí)間: 2025-3-30 18:21
Designing the Administrative Stateion exams for research staff, including certifications for CCRC, CCRA, CPI, ACRP-CP, and CCCP certifications. Financial incentives, including payment for traveling to national meetings, reimbursement for certifying exams, and bonuses for obtaining additional training should be an integral part of every good clinical research team.作者: Tractable 時(shí)間: 2025-3-30 21:53
How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect,scovered to codify the protection of human subjects and ensure voluntary consent. After the US Tuskegee Syphilis experiment came to light, the Belmont Report in 1979 delineated the three principals of respect for persons, beneficence, and justice. It also established the system of Institutional Review Boards to oversee research on a local level.作者: 環(huán)形 時(shí)間: 2025-3-31 03:56 作者: Encumber 時(shí)間: 2025-3-31 07:59 作者: 大喘氣 時(shí)間: 2025-3-31 09:25
Starting the Study,t subject is enrolled, the team should have a mock subject drill. After enrolling the first subject, a Study Update Meeting should be scheduled to debrief the initiation steps of the study completed so far. Finally, it is important to insist on having the first monitor visit early so that misunderstandings can be corrected.作者: Ardent 時(shí)間: 2025-3-31 16:04
Getting Subjects Through the Door,trust and be willing to listen to the subject’s questions and concerns. Being able to expound on the advantages and disadvantages of being in the research study is especially valuable for the research subject. Free parking, a stipend for each visit, and reimbursement for travel can also be helpful.作者: 別炫耀 時(shí)間: 2025-3-31 20:40
Staff Training and Incentives,ion exams for research staff, including certifications for CCRC, CCRA, CPI, ACRP-CP, and CCCP certifications. Financial incentives, including payment for traveling to national meetings, reimbursement for certifying exams, and bonuses for obtaining additional training should be an integral part of every good clinical research team.作者: 建筑師 時(shí)間: 2025-4-1 01:40
Erblin Berisha,Giancarlo Cotella,Alys Sollylling a widely generalizable population in clinical research, involve enlightened clinical research personnel and protocols in the work being done, and meaningfully contribute to how medicine is practiced today.作者: shrill 時(shí)間: 2025-4-1 02:59 作者: 搖擺 時(shí)間: 2025-4-1 07:54
Urban Governance in a Devolved Kenyautional review boards (IRB). The contract sets out the specifics of the compensation and schedule of payments. Other clauses address the investigational product, use of equipment, and audit procedures.作者: Tidious 時(shí)間: 2025-4-1 13:01
Educational Governance Researchn extend the site’s reputation. Electronic health records remain the biggest breakthrough in recruiting subjects, as long as some specific rules are followed. The future lies in social media, where the motivated subjects can self-select.作者: absolve 時(shí)間: 2025-4-1 17:16 作者: formula 時(shí)間: 2025-4-1 21:44 作者: regale 時(shí)間: 2025-4-2 01:29
Environmental Justice and Global Democracys responsible for the budget, the contract, and the monitoring of the study data. As such, the site needs to have a plan to optimally handle study monitors and minimize their interruption of ongoing study activities, which may include feeding back to study managers when necessary.作者: 抵消 時(shí)間: 2025-4-2 03:48 作者: 炸壞 時(shí)間: 2025-4-2 10:11
https://doi.org/10.1007/978-3-031-09996-0t template should also include sections for the phone correspondence, con meds, AE and SAE lists, study endpoints, protocol deviation log, study drug dispensing log, IVRS randomization contacts, inclusion and exclusion criteria, and patient consents.作者: 安裝 時(shí)間: 2025-4-2 13:35
The Screening Visit,t template should also include sections for the phone correspondence, con meds, AE and SAE lists, study endpoints, protocol deviation log, study drug dispensing log, IVRS randomization contacts, inclusion and exclusion criteria, and patient consents.作者: Hippocampus 時(shí)間: 2025-4-2 18:25
The Governing Properties of Numbersd efficacy (100–300 subjects), phase III firmly establishing safety and efficacy (300–3000 subjects), and phase IV post marketing for further information. There are some high-risk procedures (such as those involving radiation therapy or viruses that require special approvals.
