The Introduction provides the purpose and relevance of your experiment in relation to current research. You should write it using past tense (e.g. “Smith (2009) found that…”).
The Materials and Methods section walks the reader step-by-step through the laboratory procedure that was utilized for conducting this study. It should provide enough details so that an experienced scientist could replicate these experiments with ease.
How to Initiate a Clinical Trial
Clinical research organization involves studying people to gain a better understanding of health and illness.1 This type of research may test new drugs or combinations; surgical procedures; devices; treatment methods or new ways of using existing treatments that were already proven.2 Research may be supported by private organizations (pharmaceutical companies) or Federal offices/agencies such as National Institutes of Health/U.S. Department of Veterans Affairs as well as conducted at universities, medical centers hospitals or clinics.
Before commencing a clinical trial, researchers must create a study protocol – this outlines all steps required for safely and accurately collecting data on health effects from new drugs or devices. After approval by both research team members and an independent review board (IRB), which includes both medical experts and members of the public who are not directly involved with research projects, trial can commence.
Finding people willing to participate is the next step of any study, which typically means recruiting patients at local health care facilities via patient databases, newspaper and radio advertisements, flyers posted around places frequented by patients and personal recruitment by investigators. Once participants are found they will be enrolled into the study based on inclusion/exclusion criteria outlined in its protocol.
Investigators obtain and store an investigational product appropriately before monitoring its use according to its study protocol. A sponsor may manage this product directly or use a contract research organization as necessary.
How to Establish a Study Team
Clinical research involves translating basic science conducted in laboratories into new treatments and information that benefit patients, including studies of physiology and pathophysiology, epidemiology, health services provision, education outcomes as well as mental wellbeing.
Successful studies require an experienced team with complementary expertise and skills. When choosing CRO partners, sponsors typically look at organizational experience and therapeutic areas of expertise as a basis for selection; however, sponsors should also assess hands-on team experience levels when selecting CRO partners.
Once you’ve assembled a group, arrange to meet regularly as a study group. This will keep everyone on task and prevent it from turning into more of a social group than intended. Furthermore, identify which roles each member will fill during meetings; perhaps someone serves as agenda-maker while another acts as teacher during meetings.
As a rule of thumb, it is recommended that study groups consist of between three and five members in order to ensure everyone can participate and ask questions freely. Larger groups will find it more challenging to find a time suitable for all members; additionally, staying focused will likely become harder with more than five people present; meetings will become less fruitful due to discussions that cut across one another’s words.
How to Set a Budget
Preparing a budget is an integral component of clinical trial research. Doing so allows you to understand what to expect in terms of time and costs from the study as well as prepare for potential issues that might arise such as unexpected expenses or delays.
Budgeting can make your research more competitive, whether applying for National Institutes of Health funding or working with an industry sponsor. But creating one isn’t simple – set aside several months in order to prepare.
Consider all costs related to your study, from principal investigator (PI) time and effort, staff time, supplies, facility charges and other indirect costs to how to calculate cost per subject enrolled – this will enable you to accurately bill sponsors for every phase of the research project.
Assembling all this information will make negotiating with sponsors much simpler. Although budget negotiations may seem intimidating at first, the process isn’t that different from any other purchase: be aggressive to increase your chances of securing an excellent deal! Communicate frequently with sponsors throughout the entire process in order to build their trust in you as an expert and lead to better financial and clinical results.
How to Prepare for IRB Review
When conducting clinical research, studies must first be reviewed and approved by an Institutional Review Board (IRB). The IRB ensures that the rights of people participating are safeguarded; they assess plans for studies to reduce risks as much as possible for participants.
Before making their submission to an IRB for review, Principal Investigators (PIs) should ensure they have all of the required documents ready, such as consent forms, advertisement scripts and more. Missing or incomplete information may lengthen the review process so it’s wise to collaborate closely with faculty sponsors who will review all required paperwork prior to sending it in to IRB for approval.
As part of its review process, the Institutional Review Board (IRB) examines all aspects of research projects such as who is being recruited for study participation, whether recruitment methods are fair and equitable, what benefits will individuals participating in the research stand to receive from taking part, data protection/storage plans being utilized, risks beyond normal life exposure associated with participating, etc. In addition, recruitment materials will be scrutinized by IRB to verify they do not contain claims that are false or misleading.
All Principal Investigators and Student Principal Investigators must undergo Human Subjects Protection Training (CITI). Furthermore, when their studies are being reviewed by an IRB committee meeting it is strongly encouraged that both Principal and Student PIs attend. IRB meeting dates and times can be found on its homepage.
How to Create a Study Protocol
Research protocols are documents which outline a clinical study’s plan in terms of meeting ethical norms for participating subjects. A research protocol serves multiple functions, from funding acquisition and administration, through ethics approval by IRBs within universities or research centers, all the way to ethics review boards to ethics approval of research studies.
A comprehensive protocol should include the following elements:
Research questions/hypotheses, objectives and the research design must all be clearly presented before diving into the methods section of the paper. Here you should provide sufficient details so that another investigator could easily replicate your study and reach comparable results.
Detail the roles and responsibilities of every member of the study team, such as the principal investigator (PI) and co-investigators; including their CVs in this section.
An outline of the timeline for completion of the study. This should include starting and ending dates of the research project, possible control examinations and when data analyses will start. Long term studies should include provisions for a Data and Safety Monitoring Board as part of this section; additionally a description of quality control and assurance should be provided that includes Good Clinical Practice guidelines followed up by clinical monitors as well as availability of a data manager is key to ensure participant safety.
How to Manage a Study
Research lab success relies on its ability to efficiently organize various tasks. From setting project timelines, managing grants and inventories, reviewing process documentation, improving workflow and collecting and organizing data quickly are just a few key responsibilities a research laboratory must fulfill in an expeditious fashion.
Effective lab management involves cultivating collaboration and communication among team members. Setting collaborative goals and regularly checking in with each member can help reduce miscommunication and promote an inclusive atmosphere within the laboratory, while project management tools and collaboration platforms can increase efficiency by simplifying document sharing and task tracking.
Last, but certainly not least, it is crucial to keep in mind that each member of a laboratory is unique with different strengths, ambitions and motivations. Successful laboratories take time to get to know their team members well and provide meaningful work that provides personal fulfillment – this may involve setting emotionally satisfying goals as well as tapping into individuals’ passions so that skills development occurs independently of institutional demands.Every clinical research companies must regularly evaluate project scope, timelines and workflows in order to meet trial goals. This can be achieved through regular team meetings as well as creating a shared project management system to track tasks, communicate updates and share knowledge.
