When it comes to using clinical data collected outside of the US to support a US regulatory submission, it’s important to understand that:

a. FDA expects clinical trial design and conduct to conform with relevant local regulations and applicable Good Clinical Practices

b. FDA looks critically at data obtained from foreign studies in terms of its applicability to the US patient population

c. FDA reserves the right to audit foreign clinical sites to confirm whether or not the data is valid for the purposes of obtaining an approval to market a device in the U.S

d. All of the above

I need a 5 paragraph lab report completed with this information. Asap.

After having studied Circulation/Respiration and Digestion, it will be very important for us to look at and put into practice one important aspect of the thread that ties these three aspects in terms of one of the elements known as the DIVERSITY OF MICROBES.

=>> > As you prepare to complete this lab and ready to write your final report, ensure that you are able to answer the following questions and incorporate your answers/responses in the specific sections of your written lab report

(1) What is aseptic technique?

(2) What are microbes?

(3) What media is being used in the lab?

(4) What inoculum is used in the lab?

(5) Why was a control used for this experiment?

(6) How will you store your agar plates?

First paragraph Must include background information for the lab, objective (s) of the lab relation to the class materials.

Second paragraph is about Relevant materials and methods used, Steps used to carry out the lab, Measurements taken

Third paragraph must have Record of all the results obtained, Tables, graphs, pictures, drawings, Other observations relevant to the label exercise.

Fourth paragraph must Explanation of all results in relation to the objective of the lab, Interpretation of the data lab according to the data collected or observations make or taken during the lab.

Fifth paragraph must be a Summary of your findings and the interpretations of the data in relation to the objectives or aim of the lab and relationship to the class topic, etc. Recommendations, if any.

Prepare Notes

Outline your response to the prompt in the box below. Then, write a few questions to ask your peers to better understand their environmental outlooks.

I bring a variety of experiences, attitudes, and perspectives when considering environmental science issues. Firstly, my experiences living in both rural and urban environments have given me the opportunity to see firsthand the various environmental challenges faced by different communities. Additionally, I have been fortunate enough to have the opportunity to travel and see the impacts of environmental issues on a global scale. These experiences have fostered within me a deep appreciation and respect for the natural world and a desire to protect it.

In terms of attitudes, I am strongly motivated by a sense of social and environmental justice. I believe that it is our responsibility to be stewards of the planet and to ensure that future generations have the opportunity to enjoy a healthy and sustainable environment. I also believe that addressing environmental issues requires a holistic and intersectional approach, considering the impacts on both human and non-human communities.

As for perspectives, I approach environmental science issues with a scientific mindset, valuing evidence-based decision making and a willingness to consider multiple viewpoints. However, I also recognize the importance of incorporating indigenous knowledge and the perspectives of marginalized communities into the conversation.

Questions for Peers:

What experiences have you had that have shaped your environmental outlook?

What values do you prioritize when considering environmental science issues?

How do you approach environmental issues from a scientific perspective?

How do you incorporate the perspectives of marginalized communities into your understanding of environmental science issues?

Final Product: Socratic Seminar on Sustainability

Instructions: For this final product, you will engage in a college-style Socratic seminar on sustainability. You will submit your Preparation notes, and use those notes to support you as you actively listen and contribute to the discussion.

Preparation

Paste your final Preparation notes below.

Before the Discussion

As you get ready for the discussion, set at least two specific goals for your participation during the discussion. Use the  Contributing to Evidence-based Discussions and Norms/Active Listening rubrics in the Platform to inform your goals.

Sample Goals:

I plan to share at least one piece of information from my Preparation notes during the discussion.

I plan to connect my ideas to something another person says during the discussion.

What is your first goal?:

What is your second goal?:

After the Discussion

To what extent did you accomplish your first goal?

To what extent did you accomplish your second goal?:

How did you do with CONTRIBUTING TO EVIDENCE-BASED DISCUSSIONS? Give yourself a score based on the Cognitive Skills Rubric and explain why you deserve this score:

How did you do with NORMS/ACTIVE LISTENING? Give yourself a score based on the Cognitive Skills Rubric and explain why you deserve this score:

What did you enjoy or find the most interesting in the discussion?:  

Was there anything you wish the discussion talked about but didn’t?:

Any other notes or reflections on today’s discussion: