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The eCOI module allows organizations to comply with conflict of interest guidelines without inconveniencing their researchers. OverviewThe eCOI module helps organizations collect disclosures from investigators in a simple and convenient format. Researchers can disclose relevant engagements quickly from anywhere, without interrupting their research activities.

Features

stem cell protocol Automated eCOI system Annual disclosures can be easily managed with our eCOI system, which allows administrators to create and submit Conflict Disclosure forms, make necessary amendments, speed up renewals, and more.

Timely Notifications The COI management system is integrated with your database. Reviewers are automatically alerted about changes and imminent conflicts. Reminders are sent to researchers notifying them about due disclosures.

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Simplified Management With eCOI, Investigators can track, report, and update COI disclosures anytime and anywhere. The system automates the COI disclosure process and saves time by avoiding potential conflicts.

Biosafety can be defined as the application of information, techniques, and equipment to prevent potentially infectious and/or hazardous biological materials from harming people and the environment. Biosafety measures delineate the conditions under which biohazardous materials and agents can be safely handled. Biohazardous materials could be microorganisms, toxins, body fluids, controlled substances, allergens, carcinogens, oncogenic matter, and genetic material such as DNA and RNA (including genetically modified DNA).

Over the years, there have been numerous incidents around the world involving biological harmful agents, which have emphasized the importance of management of biosafety in research laboratories, especially those working with biological materials. Biosafety management is an extremely critical function of any research organization, in order to ensure the following:

clinical trials

Prevention of accidents and laboratory-acquired infections

Protection of the environment from hazardous biomaterials

Compliance with federal, state, and other organizational regulations

The Centers for Disease Control (CDC) and the National Institutes of Health (NIH) have put forth four biosafety levels – in increasing order along with the hazardous nature of the biological material being used. Each level indicates an appropriate set of laboratory practices, equipment, and facilities, with level 4 being the most hazardous, and therefore the most stringent one.

Biosafety Level 1:

This is the lowest risk level wherein basic microbiological practices suffice to ensure protection against harmful microorganisms.

Biosafety Level 2:

At this level, other than basic handwashing stations, other safety arrangements such as eyewash stations, secondary barriers such as splash shields, gowns, gloves, etc. are mandatory. There is the danger of contamination and infection by accidental percutaneous exposure with needles or sharps.

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Biosafety Level 3:

The main dangers in this category are infectious organisms such as the tuberculosis bacillus, encephalitis virus, etc. which could be ingested, inhaled via aerosols, or inoculated by accident. Multiple primary and secondary barriers are built in at this level to prevent grave and toxic respiratory infections.

Biosafety Level 4:

The highest level of containment, this level usually involves a separate, isolated facility with very restricted access to trained and qualified personnel only. Specialized ventilation requirements and waste management systems are part of this level for effective and safe release of hazardous agents into the environment.

In order to manage the challenges of biosafety in research laboratories, regulatory authorities, such as the Institutional Biosafety Committee, are responsible for creating and enforcing guidelines and policies that ensure the safety and security of the research personnel of an organization. The IBC thoroughly vets and checks the compliance records of an organization or laboratory before it grants its approval to perform experiments with biohazardous agents.

To get approval of the IBC, various compliance records have to be furnished, applications have to be made and followed up, and so on. Once all the documentation is in place, the committee may recommend allowing work with biohazardous agents in the institution.

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The documentation for obtaining IBC approval, like for any other approval process, can be tedious, time-consuming, and can take the focus of the researcher off the subject of research. Hence it is highly useful for a research lab to have a software system, such as that provided by Key Solutions, that automates the entire process of application for approval.

Far reaching and Integrated Post Approval Monitoring

Exploration is the foundation of progression in science. Clinical specialists invest energy and cash looking for solutions for some infirmities. For this, they need to uncover creatures and people to an assortment of untested, obscure components. Guarantee that these examinations are directed according to set rules.

Post Approval Monitoring (PAM)

The Institutional Review Board (IRB)and Institutional Animal Care and Use Committee (IACUC) assume an essential part in the execution of Post Approval Monitoring (PAM). IRB and IACUC are the administering bodies that have spread out the convention the human and creature examination ought to follow to guarantee the wellbeing of people just as creatures. PAM deals with two primary objectives for all exploration establishments – ensure that their examination meets every one of the administrative necessities and teach the examination groups on the prescribed procedures for completing human and creature research considers.

While IRB's principle intention is to protect the human examination subjects, it additionally helps and supports the analysts in arranging their investigations to affirm their consistence with endorsed conventions. It helps in checking the PAM interaction and features the need to teach the analysts on the appropriate direct of the cycle.

IACUC evaluates creature's utilization inside the lab through semi-yearly review (SAI) of creature care offices to ensure the proposed conventions are rigidly followed. PAM (for IRB and IACUC) evaluates various boundaries identified with the examinations like: number of creatures utilized, preparing of the exploration staff, utilization of suitable drug, appropriate documentation, screening systems, announcing of unfavorable occasions, subject installment, assent measure, subject enlistment interaction and that's just the beginning.

Post Award management

Additionally, IRB audits the human preliminaries occasionally to guarantee the wellbeing of the examination subjects. Its point is to ensure that the exploration isn't placing the members in any danger. The survey additionally centers around the determination of the members, interchanges with the members in regards to the dangers and advantages of the exploration, fitting assent from the members and information checking for the examination.

Another critical point of PAM is to keep all faculty associated with research work to keep up to date with the most recent systems and strategies laid out by the specialists.

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Advantages of PAM:

1. Guarantee the prosperity of the subjects and creatures – conventions are set up to ensure that the examination subjects are not hurt at all. While guaranteeing the rules are being followed, the PAM cycle helps keep a mind the progressing exercises. This shields the subjects – creatures or people. It verifies that they are treated according to the set conventions and don't get mishandled during the exploration.

Distinguish any deviation from convention – checking helps in recognizing where the cycles are inadequate with regards to consistence. PAM gives a review like stage to associations to survey their inward exercises and decide any uniqueness from the convention.

Guide self-detailing of deviations – abnormality from the administrative rules is consistently a chance. The PAM interaction, notwithstanding, gives direction on revealing any holes found during the execution of the standard methods.

Execute remedial activities sooner – conventions are set up to defend the subjects and the association too. The PAM cycle gives a self-evaluation stage to the associations to distinguish deviations and make restorative moves quickly to keep up consistence with the conventions.

electronic research administration software

Increment comprehension of administrative rules – constant observing of the cycles and contrasting them with the conventions set up offers the association a chance to comprehend the administering implicit rules better and ultimately have the option to follow the rules consistently.

Admittance to assets and people to explain guidelines – the PAM interaction includes some significant jobs including from the administrative specialists. This gives the associations a definitive source to connect with in the event that there are any inquiries to comprehend the conventions better. This assists association with turning out to be and stay consistent with the guidelines.

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The US Federal Government provides financial support in the form of grants to individuals and institutions for research in the areas of public interest or wellbeing of common citizens. The projects are funded out of the general federal revenue.  The federal government has a website ‘grants.gov’ as a single access point for all types of grants. This site has a page titled ‘Learning Center’.

The ‘Learning Center’ of grants.gov is, in essence, the gateway to federal grants. This page provides detailed information about the categories of grants, the policies, eligibility, the programs, terms and conditions of award, agencies handling grants and other necessary information. These help an aspirant to pick up the right category of grant for his /her project.

clinical trials database

Once you have picked up the category of grant that is most suitable for your/your organization’s project, you will need to get yourself registered with grants.gov. After you are registered, grants.gov will assign a unique workspace to you for your grant management.

The assigned workspace on the site is like a dashboard for you to create and organise your documents connected with your application for a grant. The main features are as follows:

You can access and edit a number of forms simultaneously within an application.

You can fill up the forms online or these can be downloaded and filled up offline as per your convenience.

You can create your own application workflow.

If the applicant is an organisation, it can create custom roles for its affiliates and assign the same to them. For this, the affiliates will also have to be registered with grants.gov.

Post Award management

The offline PDF forms can be seamlessly integrated with the online forms.

The forms on the workspace are reusable. This helps reduce duplication of effort during the process.

You can validate your data to check errors, if any, before submitting your application. This helps to reduce the chance of rejection on technical grounds.

You can also invite external organisations to help you to prepare the documents for submission.

post award grants management

Once the application is complete in all respects, the same can be submitted directly from your workspace. The workspace also has the facility to track an application till its final disposal.

Most of the agencies insist on submission and processing of applications digitally. Key Solutions has developed a web-based module called eGrants.  This module makes grant management pleasingly simple. It is a user-friendly and versatile tool. It provides the necessary solution and clarity to various queries of an applicant. This not only accelerates the process of grant management, but also enhances the chances of getting a grant. eGrants also facilitates post-submission tracking of the applications until the same are finally awarded.

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Divulgences – Paper structures. Accounting pages. Records. Divergent frameworks and information trade designs with no standard cycle to oversee, plan and relieve hazards. The assignment of overseeing revelations and irreconcilable situations they achieve forward is to get harder – with labor forces developing, going worldwide, and moving social assumptions. Your COI the board needs to develop as well. It needs a tech overhaul.

eprotocol

Before we examine the innovation required for COI that works for the present and future, we should talk somewhat more regarding why such innovation is required today.

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Irreconcilable situation:

An irreconcilable circumstance (COI) is a circumstance wherein an individual or association is engaged with different interests, monetary or something else, and serving one interest could include neutralizing another.

The irreconcilable situation in the medical care setting happens when the essential objective of securing and improving the wellbeing of patients clashes with some other optional objective. Optional objectives typically include individual addition to medical care experts or expansion in income to medical services association from selling medical care items and administrations.

Post Approval Monitoring IACUC

The strife of Commitment:

Clashes of responsibility are by and large circumstances in which an expert is committing time to exercises in the abundance of the time allowed by institutional arrangement, or to exercises that may redirect from essential obligation to the foundation. The issue here isn't restricted to monetary misfortune or one-sided judgment, but instead the actual reason of responsibility of time and exertion being conflicting with one's obligation to the establishment and its inclinations.

"Post award grants management Software from Key Solutions helps streamline this process and keep things clear and straight forward for auditing purposes."

Post Approval Monitoring IRB

Proposition Tracking:

Monitor the status of your undertaking proposition with the assistance of programming to transfer and handle the Notice of Award as per arrangements and task expectations.

Organized Spending:

Our particular programming module for the administration of award grants assists with making and keep a spending plan that is organized by the particular necessities of the examination program and its prerequisites. It additionally imports and shows use information from institutional monetary frameworks in an easy to use and recognizable configuration.

Post Award management

Grant Audits:

Key Solutions' eProtocol IRB framework mechanizes the administration of examination with human subjects. The whole application measure – including improvement, accommodation, following, survey, endorsement, review, etc – is acted in a smoothed out, paperless organization, giving adaptability and guaranteeing blunder-free consistency with guidelines.

Chemical safety committee

'Coming up next are a portion of the striking highlights of the eProtocol IRB programming:

Keen structures the board

online convention accommodation

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underpins audits, corrections, restorations, unfriendly occasions, and deviations

Paperless audit

age of meeting plan and recording of meeting minutes

Standard and specially appointed reports

convention the board and form control total review trails

With dynamic, configurable structures and work processes the executive's apparatuses, the IRB programming makes the mind-boggling cycle of convention endorsement application very straightforward, adaptable, and simple to oversee.

Unified Access:

The convention application is made, submitted, and investigated electronically, eliminating conceivable outcomes of information repetition and human blunder. All partners – head specialists, research organizers, analysts, and the IRB Office – approach one regular application form.

animal breeding colony

Mechanize the Approval Process:

While applications keep on being affirmed by a board of specialists, routine undertakings, for example, meeting the executives, plan setting, record directing, and email warnings are computerized by the item. A programmed "Check for Completeness" is performed before convention accommodation to guarantee that the application is finished.

IRB Protocol Software

Announcing:

A whole history of structures, remarks, connections, notes, plan, and meeting minutes is kept up for every convention application.

iacuc compliance software

Coordination with Other Modules:

The IRB convention consistence module can be coordinated with other eProtocol modules, for example, IBC, SCRO, RSC, CSC, and CS. Further, the IRB module can likewise fit hand-in-glove with our Grants Management and Conflict of Interest modules.

Our IACUC consistence module encourages the audit and observing of each examination convention including creatures, both USDA species and something else.

Highlights:

Exhaustive Review: Animal research needs to agree to USDA guidelines and authoritative strategies for the consideration and utilization of creatures. Our item encourages head specialists to make and submit definite convention applications for endorsement from the IACUC Committee.

Convention Amendments:

Research approach frequently develops over the span of an examination study. Head Investigators can then rapidly add a correction to their endorsed convention and get acknowledgment from the IACUC Committee. This streamlined procedure limits interference to the progressing research.

iacuc compliance software

Record Version Control:

A primary specialist may adjust the convention application a few times dependent on the criticism from the IACUC Committee or change in look into system. The application keeps up a background marked by totally submitted forms of the convention application with the goal that the exploration organizers can get to any emphasis for reference.

irb regulations

Joining with Other Modules:

The IACUC convention consistence module can be coordinated with other eProtocol modules, for example, IBC, SCRO, RSC, CSC, and CS. Past consistence, we additionally bolster the creature examine process with our Facility Management (LARS) and Lab Animal Health Program (LAHS) modules.img

Overview

Our creature explore framework encourages IACUC consistence, office the executives and creature wellbeing the board.  

Creature look into requests stringent consistence. It additionally includes entangled office the board and wellbeing record the executives forms. The Key Solutions creature inquire about modules rearrange and streamline these procedures for examiners, LARS staff, and veterinarians, empowering better research at lower costs.

Guarantee that all your creature explore conventions are consistent with IACUC guidelines.

Review:

Our IACUC compliance module facilitates the review and monitoring of every research protocol involving animals, both USDA species and otherwise.

To Know More: research compliance

Highlights:

Exhaustive Review:

Creature investigate necessities to agree to USDA guidelines and hierarchical approaches for the consideration and utilization of creatures. Our item causes head specialists to make and submit point by point convention applications for endorsement from the IACUC software

Convention Amendments:

Research procedure regularly advances throughout an exploration study. Head Investigators can then rapidly add a correction to their affirmed convention and get acknowledgment from the IACUC Committee. This streamlined procedure limits interference to the continuous research

Archive Version Control:

A foremost examiner may adjust the convention application a few times dependent on the criticism from the IACUC Committee or change in investigate approach. The application keeps up a background marked by completely submitted forms of the convention application with the goal that the examination organizers can get to any cycle for reference

Reconciliation with Other Modules:

Presence (or supposition) of a Conflict of Interest (COI) can possibly risk an exploration undertaking and stain the notoriety of the examination association leading the examination. A significant piece of research organization is to take out presence of COI before it can damagingly affect the examination being performed. As a piece of this procedure, scientists need to submit money related divulgence structures when they present a proposition for getting assets for their examination, when they get the budgetary awards, and when they present a convention for a human or potentially creature study.

For any exploration association, orchestrating reserves is a significant and basic advance that empowers it to convey forward innovative work. Awards – government or private – are one method for getting the genuinely necessary assets. Beginning from applying for awards and making sure about them, to dealing with the assets mindfully, the procedure should be straightforward, careful, just as precise to guarantee future financing from the grantors. Inappropriate administration of awards could make continuation of a present award or new subsidizing from grantors troublesome. Subsequently, award the board is a basic exercise that envelops an extent of exercises and staff.

Programming arrangements suppliers offer electronic projects that can assist specialists with the monotonous, yet fundamental strides of award the executives, directly from readiness and accommodation to survey and following of the award application. The incorporated, online access given to specialists, executives, and commentators makes the use straightforward and powerful, disposing of blunders and sparing important time. This additionally serves to improve correspondence among the examination group.

With an effective award the executives programming close by, all you need are the five hints offered beneath to help in effectively overseeing awards got by your association:

1. Compose the ideal proposition:

The initial step of award the executives starts even before the award is granted. Composing a great award proposition is the way to guaranteeing gift of the award cash upon the candidate association. Instead of simply posting the goals of the association with respect to the undertaking, present considerable specialized support in the proposition to convince the giver. Incorporate instances of past work records and references for believability. Nowadays, programming projects can redo an award application for a specialist, making it simpler and increasingly sensible.

2. Keep up precise records:

From the time that an award is applied for, carefully record all insights about the task, viz. the date the award application is presented, the outcome – acknowledgment or dismissal, the measure of award granted, the reasons given for dismissal, etc. Appropriately note and keep up the subtleties in a database, for record-keeping as well as for simplicity of sharing among award beneficiaries. This strategy thinks about obligation and responsibility the piece of the association mentioning the award. In addition, if there should arise an occurrence of any debate, all subtleties and records will be promptly accessible for cross-checking and explanation.

This is one basic zone where electronic programming programs are important. Record-keeping all things considered, sums, cutoff times and other significant subtleties can be effectively followed utilizing programming. A few projects have email notice frameworks to empower convenient admonitions of moving toward cutoff times of entries and so forth., in this manner decreasing odds of blunders.

3. Seek after administrative consistence:

Be very knowledgeable with the guidelines administering the award grant. These remember rules for the utilization of the award cash, the support of records of consumption, and so on. While there are a few rules that are uniform across establishments, there will be some particular guidelines for look into associations that ought to be clung to by all applicable work force.

4. Follow best practices:

As an expansion of consistence, guarantee that you follow best practices in all regions – accounts, money the executives and cost following, staff the board, records, progress reports, timekeeping, obtainment, travel approaches, and so on for powerful award the executives. Award the executives programming can be exceptionally helpful in guaranteeing consistence in every one of these regions, disentangling dull, however critical occupations, for example, record keeping, cost following, and so forth.

5. Characterize jobs and duties:

It would be a misstep to accept that the accountability of overseeing awards lies exclusively with the award author, or the fund supervisor. At each degree of the association, directly from the Board individuals, to the lab professional chipping away at the award subordinate research venture, all representatives ought to be engaged with the functions of the assets got by means of awards. By designating and offering duty to everybody, you can make an increasingly equitable and responsible environment for capable utilization of award reserves. Each laborer ought to be urged to be conscientious in bookkeeping and money the executives propensities.

Right now, award the executives programming can energize and empower joint effort and correspondence among the examination groups.

Remembering the above focuses, and with productive award the board programming programs available to you, you can adequately deal with any award cash got for research or advancement forms.

Research grants funding software from Key Solutions helps researchers prepare their grant applications, get internal approvals and submit to funding agencies. Researchers can prepare their grants applications, route it for internal approvals, and submit it to the funding agency with the Key Solutions eGrants module. The online platform also supports sub-award funding and post-award budget management of the grants. The S2S feature allows direct online submission to funding agencies such as grants.gov.

Document your research proposal and apply for funds on a secure platform. eGrants recognizes the mandatory forms for each funding opportunity and automatically saves the sponsor’s contact information system. Our research Grants funding system automatically identifies errors in submission and prevents delays due to oversight with integrated tools and agency validations. Process IntegrationThe eGrants module supports the entire grants management workflow from research proposal to receiving the award and monitoring its expenditure. Further, integration with modules such as IRB and IACUC ensures compliance during research.

Key Solutions eProtocol IRB system automates the management of research with human subjects. The entire application process – including development, submission etc. Key Solutions’ eProtocol IRB system automates the management of research with human subjects. The entire application process – including development, submission, tracking, review, approval, audit, and so on – is performed in a streamlined, paperless format, providing flexibility and ensuring error-free compliance with regulations.

Key Solutions offers Post-Approval Monitoring which facilitates regular inspection of protocols and enables immediate correction if required.

After the approval of a protocol, an organization needs to continuously monitor its activities to confirm that they are in line with the compliance application. If there are any discrepancies, the inspection team should either prescribe corrective action or, in extreme cases, suspend the research protocol. Our PAM module streamlines this entire process.