#bpharmajobs

[iimtcollege]

Pool Campus Placement Drive - Calling B.Pharm Graduates!

Don't miss this chance to kickstart your career with Health Plix. Join us at the Pool Campus Placement Drive and take the first step towards a rewarding professional journey! . https://www.iimtindia.net/ Call us: 9520886860 . #IIMTIndia#IIMTNoida#IIMTGreaterNoida#IIMTDelhiNCR #CampusPlacement#HealthcareCareer#OpportunityAwaits#HealthPlix#BPharmaJobs

[siroclinicalresearchinstitute]

Informed Consent ( IC ) Waiver in Clinical Trials I Clinical Research

What is a waiver of informed consent? Waiver of Documentation of Informed Consent (45 CFR 46.117) This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document. What is a waiver in clinical trials? A Protocol Waiver may be defined as the sponsor approval for a prospective protocol deviation. Such deviations can often involve (but may not be limited to) the active recruitment to a study of one or more participants who do not meet the inclusion/exclusion criteria as detailed in the study protocol. What is the criteria for waiver of documentation of informed consent? For research that is FDA-regulated, a waiver of documentation of consent may be granted only: When the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context. What is the difference between a waiver and informed consent? A waiver is legal document releasing or relinquishing a known right, claim, or privilege. In this context, it is the relinquishment to pursue a claim in a certain set of defined circumstances. Informed consent is a written acknowledgement that a participant understands the risks inherent in a particular activity. Inform consent:- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate Inform consent Waiver:- It is a process in which informed consent is not obtained from subjects, or that eliminates or alters some (or all) of the elements of informed consent as set forth in Federal regulations (45 CFR 46.116d) The IRB must ensure that the following 4 criteria are met prior to approving a waiver or alteration of consent: The research poses no more than minimal risk to subjects The research does not adversely affect the rights and welfare The research not practicable without the waiver Whenever appropriate. The subject will be provided with pertinent information after participation Siro Clinical Research Institute. www.siroinstitute.com Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing. #Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring    

[sudheervanguri]

Medical coding Recruitment Drive at Vijayawada for all Lifesciences Candidates 2022 #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZ3RiIThE6b/?utm_medium=tumblr

[svsglobal17]

We are looking the facilities for Pharmacy College at Bikaner, Rajasthan location for the programs BPharma, MPharma and DPharma. Interested candidates do apply at - svsglobaljobs@gmail.com Regards Www.svsglobal.biz Ph: 8888588826 #svsglobal #svsglobal17 #svsglobaljobs #svsadmissions #svsadmission #bpharmacy #bpharm #bpharma #bpharmacy💉💊 #bpharmacystudy #mpharm #mpharma #mpharmacy #mpharmacyjobs #mpharmajobs #mpharmajob #bpharmacyjobs #bpharmajobs #dpharm #dpharma #dpharmajobs #dpharmacydoctors #dpharmacycollege #jobsinrajasthan #collegefaculties #collegelecturer #collegeprofessor #collegefaculty #collegeprincipals (at Bikaner-The Smart City) https://www.instagram.com/p/CSPa9ehDSUc/?utm_medium=tumblr

[siroclinicalresearchinstitute]

What Is IP? IP/ IMP – Investigational Medical Product   An investigational product refers to a preventative (vaccine), a therape​utic (drug or biologic), device, diagnostic, or palliative used in a clinical trial. What is IP manufacturing? IP Manufacturing responsibility lies with the sponsor with any applicable GMP. Any changes in the investigational or comparator product during the course of clinical development – additional studies need to be check for formulated product whether these changes would significantly alter the pharmacokinetic profile of the product. What is Labeling? The IP label contains information on : Composition Storage Requirements, expiration date (if applicable), etc. Expired and/or un-labelled IP must be quarantined and not to be dispensed. Explain expiration and retest dates to the subject. The statement: "For clinical research use only" or similar wording  Siro Clinpharm initiative www.siroinstitute.com Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing. Kindly download ppt on following link https://lnkd.in/dURGWwev #Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpang #bpharm

https://www.siroinstitute.com

[siroclinicalresearchinstitute]

What are Good Documentation Practices?

In the context of these guidelines, good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.

Inform Consent form

Investigator’s brochure

Case report form

Clinical  study protocol

Clinical study reports

Trial master file

Laboratory reports

Standard operating procedure

General Information

    Maintain records of all data and observations pertinent to the research subject.  These records should be identifiable to a particular participant.

    Remember that source documents are where the information is first recorded.

    All data must be verifiable.

    Study documentation should be able to recreate the study for any reviewer.

    Apply the ALCOA acronym for proper technique of documentation:

        Attributable – Can you tell who wrote and/or did this

        Legible – Can it be read?

        Contemporaneous- – Is the data current, and in the correct time frame?  The notation, signature and date should occur at the same time.

        Original – Has the data been altered?

        Accurate – Are there conflicting data elsewhere?  Content should precisely reflect the event.

    Use a signed Note to File to explain any discrepancies, missing or incomplete data.

Standards

    The same standards maintained for medical documentation should be followed for research documentation

    All documents require 2 identifiers on each page.

    All entries are to be signed and dated in real time.

    Error corrections are made by drawing a single line through the incorrect entry, initial and date.

    Never obliterate entries that require correction.

    Subject records need to be secure but accessible.

    Do not alter past-dated notes by writing alongside or adding to prior entries.  Updates may be made through addenda.

    Use dark ink, do not use pencil.

    Never use whiteout.

Questionnaires

    Documentation must reflect who completed the questionnaire, in compliance with the protocol.

    For questionnaires completed by staff, a note should reflect how the information was obtained ie: direct interview with participant, phone call, chart abstraction.

Kindly download presentation - https://www.slideshare.net/SIROClinicalResearch/good-documentation-practices-examples-in-clinical-trials-i-clinical-researchpptx

Siro Clinical Research Institute. www.siroinstitute.com Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing. #Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #team #fresher #project #students #development #projects #work #leaders #people #learning #culture #productivity #leader #event #clinicalresearch #clinicaloperations #clinicaldatamanagement #cdm #clinicalresearchassociate #clinicalresearchcoordinator #pharmacovigilance ,#medicalcoders ,#sas ,#SASprogrammers #Biosatisticians, #Clinicaltrialdesign, #eTMF #lifescience #medicaldevices,#scdmindia,#societyforclinicaldata #lifesciencemanagement,#pharmaceuticals,#medicalwriting #clinicalresearchinstitute #CRA #CRC #Databasedesign #pharmacovigilanceindia #CTA #pharmacist #EDC , #GCP #pharmacovigilan

www.siroinstitute.com Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing

[sudheervanguri]

Labcorp Fresher Job openings for Data Entry Support Coordinator 2022 #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZyc9wwBF8w/?utm_medium=tumblr

[sudheervanguri]

Hetero Biopharma Walk in for Production upstream & Downstream, QC Departments at Hyderabad 2022 #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZyMyIShiiR/?utm_medium=tumblr

[sudheervanguri]

1000+ Medical Coding Freshers & Experience Job weekend walk in Drive 2022 #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZyCuCmBz7i/?utm_medium=tumblr

[sudheervanguri]

Today Pharma Jobs for Fresher & Experience Candidates #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZwgInFMUB5/?utm_medium=tumblr

[sudheervanguri]

Today Pharma Job openings for Freshers & Experience Candidates #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZwfyf-MbYW/?utm_medium=tumblr

[sudheervanguri]

Today Pharma jobs #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZwMSAIsnu6/?utm_medium=tumblr

[sudheervanguri]

Abryl Laboratories walk in interview for Microbiology, Quality Control, ARD & FRD, Production & Packing Departments #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZvs-6SBkQY/?utm_medium=tumblr

[sudheervanguri]

Zydus Cadila Medical Representative walk in interview for Freshers & Experience Candidates 2022 #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZvrerTBg70/?utm_medium=tumblr

[sudheervanguri]

Lincoln Looking for B pharmacy & M pharmacy Candidates for Product management Team 2022 #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZvbOq0IUXq/?utm_medium=tumblr

[sudheervanguri]

Biological E walk in interview for B pharm, Bsc, Msc, M pharmacy, ITI, Diploma Candidates 2022 #mpharmajobs #jobsinpharmacy #bpharmacyjobs #bpharmajobs #pharmajobsnearme #pharmajobsindia #pharmajobsforfreshers #bigpharmajobs #pharmaceuticalcompaniesjobs #pharmacovigilancejobs #jobsinpharma #pharmaceuticaljobs #pharmacistjobs #pharmacyjobs #pharmajobs https://www.instagram.com/p/CZvZeadI1y7/?utm_medium=tumblr