What is protocall services?
ProtoCall Services, Inc., is the nation’s leading provider for specialty telephonic behavioral health services. Since 1992, over 275 behavioral health organizations have trusted us to provide seamless access to crisis assessment, intervention, and stabilization 24 hours a day, 7 days a week, 365 days a year.
What are the benefits of Unified Protocol therapy?
The treatment offers a simultaneous solution for comorbid conditions at a comparatively similar effectiveness to single-disorder protocols. Unified protocol reduces the burden of training because rather than having several single-disorder protocols, UP targets several disorders.
What should sponsors do after receiving a Special Protocol Assessment?
SPONSOR OPTIONS AFTER RECEIPT OF SPECIAL PROTOCOL ASSESSMENT — NO AGREEMENT LETTER Sponsors should note that, despite additional communications in writing and/or additional Type A or BPD Type 1 meetings, sponsors and FDA may not reach agreement on all aspects of the protocols and specific questions posed.
What research protocols are eligible for a request?
goals, the following protocols are eligible for a Request: • Animal carcinogenicity protocols . • Drug substance and drug product stability protocols. • Animal efficacy protocols for studies intended to provide primary evidence of effectiveness required for approval or licensure for products developed under the animal
What is a special protocol assessment?
SPA is a process in which sponsors2 may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies3 (i.e., a Request for SPA (hereafter Request); see section III., Eligible Protocols and General Information) to determine if they adequately address ...
What is a protocol in drug discovery?
The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
Who is responsible for evaluating potential risks and benefits of the expanded access treatment with the patient?
The patient's physician must determine that the probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition (§ 312.310(a)(1)).
Which of the following does the FDA require as part of expanded access?
Expanded access may be appropriate when all the following apply: Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Why is a study protocol important?
Primarily, publishing a research protocol is a means to allow the academic community to evaluate whether subsequent analysis and results are in line with the investigators' initial objectives. Additionally, it informs the academic community on ongoing research and may avoid duplication of work.
What are protocols?
A protocol is a set of rules and guidelines for communicating data. Rules are defined for each step and process during communication between two or more computers. Networks have to follow these rules to successfully transmit data.
What is the primary goal of the expanded access program?
Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside ...
Do expanded access programs require reporting of adverse events?
For device expanded access requests, sponsors must submit follow-up reports concerning the outcomes of the expanded access use, including any adverse device effects.
What is the difference between expanded and right to access?
The criteria for a patient to be eligible to request a drug under Right-to-Try are similar to Expanded Access. But with Expanded Access, the FDA determines whether the drug has the potential for a beneficial effect in a patient and an IRB must review and approve the treatment protocol.
Can a patient get access to a drug before FDA approval?
In general, to obtain access to a drug that is in testing but has not yet been approved, a patient must meet the entrance criteria and volunteer to participate in a clinical study of the drug. More information about ongoing clinical trials is available at ClinicalTrials.gov.
What is the main purpose of the Food and Drug Administration?
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
What is FDA label expansion?
Typically, when FDA approves an expansion of the indication for a drug, it means that additional clinical data have shown the drug can safely and effectively treat patient populations other than those for which it was originally intended.
That not-so-little biological process that plagues us every month
The kind of gut-wrenching (literally) pain that the more unfortunate of us have to go through during our period is the reason why I have often wished that I was born a boy. Please don’t brush off our pain like we’re being dramatic.
The pain of contraception
Maybe sex studies have advanced enough to prove that women can enjoy sex just as much as men, but until a male contraceptive pill becomes common, we are still, in a sense, paying the price for male sexual fulfillment.
Sexual responsibilities
Speaking of contraception, no method of birth control is 100% effective. So while males are walking away from pre-marital sex post-orgasm consequence-free, women are constantly faced with the possibility of pregnancy. And if pregnant, then what? Raise an unplanned child alone? Get an abortion? Again, more harm to our health.
Women are just more complicated
I don’t want to speak for all men and women, but I feel that for the most part, women just have more crap going on, which, to me, is annoying but sadly necessary.
Men are simply stronger and more fit
If there’s any basis to my parents’ advice for my college journey, then men’s physical superiority could also lead to them surpassing women in intellectual and professional achievements (assuming equal intelligence, circumstances, and effort put forth).
What is the purpose of protocol?
Protocols hold each student accountable and responsible for learning.
Why is it important to use protocols in reading?
Using protocols as the routine of every independent reading time, discussion, or collaboration will allow students to learn more effectively and, importantly, to develop the habit of taking responsibility for their own learning and for contributing to the collective understanding of the group. Resource Downloads.
What are the protocols for collaboration?
Protocols for collaboration and discussion invite students to value different perspectives and new insights. These protocols make room for listening as well as contributing to discussion. Following guidelines for timekeeping, turn taking, and focusing on the topic are essential for productive discussion.
Why are time keeping and turn taking norms important?
Time keeping and turn taking norms must be reinforced in order to maximize equity of sharing. Protocols for Critique. Protocols for peer critique are essential for teaching students how to offer and receive kind, helpful, and specific feedback on writing or problem solving.
What is norms for participants?
norms for participants (who participates and how they treat each other) specific roles for procedures (the job description for each person involved) This skeleton must be explicitly taught and rehearsed the first time a protocol is used. During successive uses, it will likely need to be reinforced multiple times.
Meaningful work but the pace and productivity demands make it unsustainable
They are a for profit organization. They bill customers a flat rate for each call they answer regardless of how involved the situation is. Therefore, the focus is on answering the phone at a grueling pace.
Good practice in suicide assessment and triage, and you never need make clinical decisions alone
You answer incoming calls which could be EAP requests for counseling or other services, crisis calls, and hospitals needing inpatient authorizations. Every second is clocked and accounted for as a factory line model. The hardest part is managing emotionally labile callers or consumers with little understanding of mental health.
Good benefits
Great benefits and pay. Remote work. Different shifts to choose from. Work can be very stressful at times. During peak call time there was little support from team leaders.
Good Work
Every call is different which helps with counseling skills. You are never alone on calls since support is alway available. Great coworkers and company
High pace work environment with a lot of learning
As a clinical specialist a typical day for me includes taking crisis calls my entire shift. This is a call center environment and we answer for an extreme number of lines. There are some moments where you can catch a breather but most times you cannot.
Stressful job, little down time
Very fast paced and stressful with little to no time to breathe after each call. They require 2 months in advance notice to use PTO forcing you to use unpaid time off, and you're only allowed a certain amount of this as well before being reprimanded. They rush you to wrap up calls with people who are in distress.
Supportive company continually working to improve itself. Great people, great pay, great culture
ProtoCall is a great place to work. You will learn new skills in crisis work daily. Your growth as a clinician will move exponentially. Everyone is supportive of you as a person and they treat you like an individual.
Why is unified protocol important?
This is because it forms the basis of using the other core skills. Unified Protocol thus stresses the need for more tolerance of emotions since they are flexible and functional. While using this core skill, UP uses mindfulness exercises in session.
What is the unified protocol?
The unified protocol is a mechanistically transdiagnostic approach treatment of emotional disorders. This means that it was developed by singling out the psychological processes that underlie the emotional disorders. The unified protocol utilizes the three main components of the ‘negative affect syndrome’ which are:
What is progressive exposure in CBT?
Progressive exposure enables a patient to face less demanding#N#situations before facing more difficult situations that provoke stronger emotions.
What are the components of the unified protocol?
The unified protocol utilizes the three main components of the ‘negative affect syndrome’ which are: Recurrent and severe adverse assumptions or emotions. Powerful reaction to the adverse affect. Substantial avoidance or evasion of the emotions. The unified protocol, therefore, targets the underlying susceptibilities of emotional disorders.
Is interoceptive therapy used for panic disorder?
disorder. These interoceptive exposures have been used for panic disorder treatment for some time. For this action the physical sensations are met which are both the disorder stimuli and also the precise nucleus for the. anxiety. In unified protocol, the interoceptive measures are not as singular treatment of a disorder.
special
2. Austral history slang a convict given special treatment on account of his education, social class, etc.
special
A very abused English word in the information industry. Phrases such as "it is a special type of format" or "it uses a special code for that purpose" are found frequently in documentation. However, anything that is newly created to solve a problem is merely another solution.
The Successes and Failures of The Spa Experience
How to Get The Most Out of An Spa
- FDA must have some knowledge of the development program prior to the submission of an SPA. Products from outside the United States or from companies with creative new formulations sometimes conduct Phase 3 early in US development, meaning that FDA must provide feedback on Phase 3 protocols while other approval rate limiting activities, such as Chemistry, Manufactur…
Considering Alternatives to Spa
- There is one alternative to SPA meetings which can help streamline the overall development process. When sponsors are seeking input on a Phase 3 protocol design and proposed analysis, the full protocol can be submitted as an appendix to your EOP2 meeting package thereby eliminating the need for an SPA. The question relating to the protocol contained in the EOP2 me…
to Spa Or Not to Spa?
- By providing FDA with a clear picture of how the results from a successful study will support the label claim for the intended indication, the SPA process can certainly be a valuable way to speed product development. Without this clear picture, though, SPA is not recommended for all development programs. If it is not yet possible to submit thorough...
Religion and Secular
- A study in the Journal of Substance Abuse SpecialTreatment suggests that people in recovery often describe themselves as spiritual, rather than affiliating with one particular type of religion. Even so, there are a number of people who feel quite strongly that their religious traditions should pervade everything they do, while there are people on the other side of the spectrum who becom…
Therapies That Are Offered
- Some patients prefer to participate in special treatment programs that provide traditional, scientifically proven forms of care. However, the Mayo Clinicsuggests that about 40 percent of adults are comfortable with the use of alternative care techniques. These patients might be more pleased with programs that offer: 1. Meditation 2. Biofeedback 3. ...
Environment of Special Treatment
- Not all special treatment programs have the same internal look and feel. Some are similar to hospitals or public health clinics, as they have a similar industrial or institutional vibe. Other facilities, including so-called luxury rehab clinics, provide patients with lovely settings, including beautifully manicured grounds and professionally decorated interiors. These luxury programs m…
Exclusions
- You Do Not Require a License if Special Treatments Are Provided in The Following Circumstances: 1. There is no reward or gain – all treatments are provided free of any sort of charge or donation 2. Treatments are not provided at premises – for example, mobile services provided from a clients’ own homes or a vehicle 3. In a hospital or nursing home, special treatme…
How to Licence A Special Treatment Premises
- You must obtain a license from the Royal Borough of Greenwich in order to offer special treatments and massages on your premises. The therapist who performs the therapy must also be a member of our database. The license is valid for one year and must be renewed every year after that. 1. Applying for A Licence– To make an application for a massage and special treatme…
After You Apply
- What you need to do?
You need to ensure all the relevant safety documents are available upon inspection at the special treatment premises (see guidance notes and application form under ‘Useful documents’ below). You also need to advertise your application by displaying a notice on the premises for 28 days. Y… - What We Do?
We’ll need to conduct a review of the special treament premises to see whether they meet our protection and licensing requirements. Before an operating license can be given, we can request that work be completed. If there are no objections to an application, the license will be accepted …
Concerning A Premises Licence
- A premises permit is issued for a certain site and specifies the kinds of procedures that can be carried out there. What is a Licensed Premise– This credential is valid for one year until it is revoked. Before the expired license expires, an application is made to extend the license; if not, a new application must be made. A License may be Modified– If you only administer special treat…
More Details
- No medical professional is expected to know about all of the addiction special treatment therapies available, and it’s unreasonable to expect that a doctor would know patients so well that matching would be a snap. However, those doctors who do take the time to really think about what their patients might want, and who are willing to spend a few moments researching treatm…