Vikas Singh
Vikas Singh
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ETMF Plan||Good Documentation Practise||Part 2||TMF Specialist Course||Clinical Trial
Hi Fam❤,
TMF Specialist is an professional who manages all the activity related to Trial Master File. So we are starting comprehensive course on eTMF where following topic will be covered:
A: What is TMF and eTMF?
Why eTMF?
B: Basic Concept:1. ALCOA (Good Documentation Practise)

2. eTMF Plan

3. TMF Index (Configuration Manual)

4. TMF Reference Model

5. Quality Check

6. Event/Milestone
TMF Health: Completeness, Timeliness, Quality Review.
C: Risk-Based Approach?
D: Basic Concept-Essential Documents
E: Current Regulations
F: Job responsibility and Scope
G:
Practical Demo
H: Quiz
So do subscribe and share as much as possible so maximum people get benefited from this series🙏🙏
Do watch this video and don't forget to leave your feedback🙏
#clinicalresearch #clinicalstudy #lifescience #pharmacovigilance #clinicaltrial #pharma #INFORMEDCONSENTFORM #PHASESOFCLINICALTRIAL #Clinicaltrial #Pharmacy #Pharmascope #Monitoringvisit #phasesofclinicaltrial #pharmacy #siv #trialmasterfile #eTMF #TMF #worldaffairs
#tmf #pharmacy #pharmacist #protocol
Join our telegram channel for getting daily updates related with Pharma job and clinical research course by clicking below link
t.me/pharmaindepthofficial
How to become Clinical Trial Assistant
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How to become TMF specialist
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What is Good documentation practise (ALCOA)?
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How to become clinical research associate
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Before doing D Pharmacy watch this video
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What is Financial Disclosure form
hiua-cam.com/video/zY6wdFVTMao/v-deo.html
What is HIPAA
ua-cam.com/video/ibXJE2zGDkA/v-deo.html
What is Patient identifiable information
ua-cam.com/video/ibXJE2zGDkA/v-deo.html
What is 1572 FDA form
ua-cam.com/video/zY6wdFVTMao/v-deo.html
What is Blinding and Unblinding in Clinical research
ua-cam.com/video/pmnO_VolugA/v-deo.html
What is IRB IEC committee in Clinical research
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Top 5 Clinical Research course for free
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Trail master file in clinical research
Trial master file
Clinical document Specialist
ETMF specialist
Regulatory document assistant
Clinical research associate
Clinical trial assistant
Site training log
Duty Delegation log
Trial staff list
Patient privacy
Clinical trials
Clinical operations
How to become TMF specialist
TMF specialist salary
TMF specialist eligibility criteria
Who are TMF specialist
Regulatory affairs
Pharmacovigilance
Medical writing
Essential Document
Clinical trial assitant salary
Clinical trial assistant jobs
Clinical trial assistant fresher jobs
Clinical trial assistant job description
Clinical trial assistant training
TMf reference​ model
DIA
ETMF
Informed consent form
Informed consent
Model informed consent form
Trial master file in Clinical Research
Informed consent procedure
ALCOA
ALCOA+
AlCOA in Hindi
Good Documentation Practice in hindi
Pharmacovigilance course in Hindi
Pharmacovigilance free course
Pharmacovigilance interview questions
Pharmacovigilance career
Pharmacovigilance course online free
Pharmacovigilance training
Pharmacovigilance jobs
Pharmacovigilance basics
Pharmacovigilance Interview Questions and Answers for fresher
Pharmacovigilance jobs for fresher
PV
Thalidomide disaster
Thalidomide Tragedy
Thalidomide disaster in Hindi
Clinical Trial Monitoring Visits
Monitoring Visit in Detail
Monitoring Visits in Hindi
What is Site Selection Visit
What is Site Initiation Visit
What is Interim Monitoring Visit
What is Site Closeout Visit
Types of Monitoring Visit in Hindi
Site Initiation Visit in Hindi
TMF specialist role and responsibility
TMF Specialist Career growth and Scope
Is TMF specialist good career?
Pay scale of TMF specialist
Top 10 TMF Specialist Interview Questions
TMF Specialist Interview Questions
TMF Specialist in Hindi
Free TMF Specialist Course in Hindi
Free eTMF Specialist Course in Hindi
Переглядів: 514

Відео

TMF v/s eTMF ||Part 1 ||Trial Master File||Clinical Research||Clinical Trial
Переглядів 7457 місяців тому
Hi Fam❤, TMF Specialist is an professional who manages all the activity related to Trial Master File. So we are starting comprehensive course on eTMF where following topic will be covered: A: What is TMF and eTMF? Why eTMF? B: Basic Concept:1. ALCOA (Good Documentation Practise) 2. eTMF Plan 3. TMF Index (Configuration Manual) 4. TMF Reference Model 5. Quality Check 6. Event/Milestone TMF Healt...
Free Course on eTMF Specialist|| Trial Master File|| electronic Trial Master File||Clinical Research
Переглядів 5937 місяців тому
Hi Fam❤, TMF Specialist is an professional who manages all the activity related to Trial Master File. So we are starting comprehensive course on eTMF where following topic will be covered: A: What is TMF and eTMF? Why eTMF? B: Basic Concept:1. ALCOA (Good Documentation Practise) 2. eTMF Plan 3. TMF Index (Configuration Manual) 4. TMF Reference Model 5. Quality Check 6. Event/Milestone TMF Healt...
Importance of Study Drug Compliance||Clinical Trial||Clinical Research
Переглядів 637Рік тому
Hi Fam❤, Study drug compliance refers to the extent to which individuals comply to prescribed medication regimen in a clinical trial or a research study. It's important for study participants to follow the study drug regimen as closely as possible to ensure accurate and reliable data collection, and to reduce the risk of adverse events. Do subscribe and share as much as possible so maximum peop...
The Dark Secret of Thalidomide||Thalidomide Tragedy||Clinical Research
Переглядів 682Рік тому
Hi Fam❤, In 1960, a new wonder drug was introduced into US market as a sedative that was said to have multiple therapeutic uses and in no time this molecule started to look as a solution to all health problem by doctors. Generic name of this molecule was Thalidomide and this drug was claimed to be too safe that in Germany this drug was given to public without any prescription The tragedy caused...
Free Course on Clinical Trial Documentation||Clinical Research||Clinical Trial
Переглядів 1,6 тис.Рік тому
Hi Fam❤, We bring you comprehensive free course on Clinical Trial document in which following documents were covered in detailed so do subscribe and share our channel so maximum people can benefit from this video. Document covered are : 1572 FDA form Clinical Trial Protocol Financial Disclosure form Accountability form Statistical Analysis Plan Monitoring Log Case Report Form Subject Log Invest...
What is clinical Study Protocol and Protocol Amendment||Types of Amendment
Переглядів 1,1 тис.Рік тому
Hi Fam❤, Clinical study protocol is a document that outlines plan of clinical trial and if any changes occurred in existing protocol during course of clinical trial then those changes referred as Protocol amendment. Do subscribe and share as much as possible so maximum people get benefited from this video🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clinical...
Clinical SAS Common Interview Question||Best Answers||Clinical Research
Переглядів 841Рік тому
Hi Fam❤, In this video common interview questions related to clinical sas covered. Do subscribe and share as much as possible so maximum people get benefited from this video🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clinicalstudy #lifescience #pharmacovigilance #clinicaltrial #pharma #INFORMEDCONSENTFORM #PHASESOFCLINICALTRIAL #Clinicaltrial #Pharmacy #Ph...
Individual Case Safety Reporting||ICSR||Pharmacovigilance
Переглядів 4,9 тис.Рік тому
Hi Fam❤, Individual Case Safety Report is a format for reporting Adverse drug reaction occur in single patient at specific period of time. Do subscribe and share as much as possible so maximum people get benefited from this video🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clinicalstudy #lifescience #pharmacovigilance #clinicaltrial #pharma #INFORMEDCONSENT...
How to become Project Assistant||Project Specialist||Clinical Trial
Переглядів 328Рік тому
Hi Fam❤, Do you want to become project assistant then watch this video Please subscribe and share as much as possible so maximum people get benefited from this vieeo🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clinicalstudy #lifescience #pharmacovigilance #clinicaltrial #pharma #INFORMEDCONSENTFORM #PHASESOFCLINICALTRIAL #Clinicaltrial #Pharmacy #Pharmascop...
Essential Documents||Types of Logs||Clinical Trial
Переглядів 2,1 тис.Рік тому
Hi Fam❤, Are you looking for GCP certification then follow all steps given in video. Do subscribe and share as much as possible so maximum people get benefited from this series🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clinicalstudy #lifescience #pharmacovigilance #clinicaltrial #pharma #INFORMEDCONSENTFORM #PHASESOFCLINICALTRIAL #Clinicaltrial #Pharmacy ...
100% Free GCP Certification that every Clinical Researchers or Pharmacy student must know
Переглядів 7432 роки тому
Hi Fam❤, Are you looking for GCP certification then follow all steps given in video. Do subscribe and share as much as possible so maximum people get benefited from this series🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clinicalstudy #lifescience #pharmacovigilance #clinicaltrial #pharma #INFORMEDCONSENTFORM #PHASESOFCLINICALTRIAL #Clinicaltrial #Pharmacy ...
TOP 10 Pharmacovigilance Interview Question with Best Answers||Part 1||Clinical Research||PV
Переглядів 6812 роки тому
Hi Fam❤, In this video,various important interview question for Pharmacovigilance is given.Question covered are; What is Pharmacovigilance What is Adverse event What is Adverse Drug Reaction What is Serious Adverse Drug reaction What is MedRA What is Medication Error What is Valid Case What is Timeline of Safety Reporting What is Medically Confirmed case Please do watch full video for full deta...
Investigator Brochure||Clinical Trial Documentation||Clinical Trial
Переглядів 2,4 тис.2 роки тому
Hi Fam❤, Investigator Brochure is a compilation of all nonclinical and clinical data related to study. Please do watch full video for full detail. So do subscribe and share as much as possible so maximum people get benefited from this series🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clinicalstudy #lifescience #pharmacovigilance #clinicaltrial #pharma #INF...
Patient Identifiable Information||PII||Clinical Research Interview Question
Переглядів 3452 роки тому
Hi Fam❤, As per your suggestion we started with full fledged series on clinical research interview tips and tricks and this is first video in which PII is covered PII is any information that can identify any person. So do subscribe and share as much as possible so maximum people get benefited from this series🙏🙏 Do watch this video and don't forget to leave your feedback🙏 #clinicalresearch #clin...
Interview Question||Clinical Research||CTMS||Clinical Trial
Переглядів 1,6 тис.2 роки тому
Interview Question||Clinical Research||CTMS||Clinical Trial
Site Closeout Visits||Part 4||Monitoring Visits||Clinical Research
Переглядів 1,5 тис.2 роки тому
Site Closeout Visits||Part 4||Monitoring Visits||Clinical Research
Top 10 TMF Specialist Interview Questions||Trial Master File||TMF||Clinical Research
Переглядів 12 тис.2 роки тому
Top 10 TMF Specialist Interview Questions||Trial Master File||TMF||Clinical Research
Interim Monitoring Visits||Monitoring Visit Part3||IMV||SDR||SDV
Переглядів 1,7 тис.2 роки тому
Interim Monitoring Visits||Monitoring Visit Part3||IMV||SDR||SDV
Pharmacovigilance Chp4||Safety Reporting Timeline||PV
Переглядів 2,1 тис.2 роки тому
Pharmacovigilance Chp4||Safety Reporting Timeline||PV
TMF Specialist-Career Growth & Scope||Clinical Research||Trial Master File
Переглядів 3,3 тис.2 роки тому
TMF Specialist-Career Growth & Scope||Clinical Research||Trial Master File
Site Initiation Visit(SIV)||Monitoring visits type||Clinical Trial
Переглядів 3,4 тис.2 роки тому
Site Initiation Visit(SIV)||Monitoring visits type||Clinical Trial
What is Site Selection Visits||Types of Monitoring Visit||Part 1
Переглядів 4,2 тис.3 роки тому
What is Site Selection Visits||Types of Monitoring Visit||Part 1
What is Pharmacovigilance||Objective & Need||Part 3||PV
Переглядів 5043 роки тому
What is Pharmacovigilance||Objective & Need||Part 3||PV
Celebrating Pharmacist Day||Thanksgiving|| 25 September
Переглядів 1383 роки тому
Celebrating Pharmacist Day||Thanksgiving|| 25 September
Basics of Pharmacovigilance|| Chapter 2||ADR,AE,SAE,Valid case,ICSR,Medically confirm case
Переглядів 1,1 тис.3 роки тому
Basics of Pharmacovigilance|| Chapter 2||ADR,AE,SAE,Valid case,ICSR,Medically confirm case
Thalidomide Disaster||Pharmacovigilance Series||Chapter 1
Переглядів 1,1 тис.3 роки тому
Thalidomide Disaster||Pharmacovigilance Series||Chapter 1
Clinical Research Coordinator||Clinical Research||Clinical Trial
Переглядів 2,1 тис.3 роки тому
Clinical Research Coordinator||Clinical Research||Clinical Trial
Understanding types of clinical trial||Clinical Research
Переглядів 9153 роки тому
Understanding types of clinical trial||Clinical Research
What is Timeliness, Completness and Quality report in Trial master file||ETMF||Clinical Research
Переглядів 1,6 тис.3 роки тому
What is Timeliness, Completness and Quality report in Trial master file||ETMF||Clinical Research

КОМЕНТАРІ

  • @ranidivekar6043
    @ranidivekar6043 20 днів тому

    Hi sir can you please make a brief video on clinical trial case processing, like investigator and sponsor causality in details, if it is not matched then what options are selected

  • @AmitSingh-k6c
    @AmitSingh-k6c Місяць тому

    Where is the course

  • @ReenaThakur-w8w
    @ReenaThakur-w8w Місяць тому

    Great video vikas.

  • @medicdk752
    @medicdk752 Місяць тому

    Helpful

  • @royalgangsters5709
    @royalgangsters5709 Місяць тому

    How much are u earning right now

  • @shaikhmadiha4404
    @shaikhmadiha4404 Місяць тому

    Thnks

  • @Pooja_4793
    @Pooja_4793 Місяць тому

    Voice clear nahi hai bro apki.Smjh ni aa raha ap kya smjha rahe ho.Be Clear in your video

  • @jitendrakushwahas7581
    @jitendrakushwahas7581 Місяць тому

    Thank you 👍 for me help

  • @payalgotmare8293
    @payalgotmare8293 4 місяці тому

    Thank you..very informative material 👍🏻

  • @gurus3608
    @gurus3608 4 місяці тому

    Thanks Vikas for eTMF explained in detail.Kindly share Milestone regarding content

  • @ankitadas6256
    @ankitadas6256 4 місяці тому

    Sir Do You Have REGULATORY AUTHORITY & DOCUMENTS FOR CLINICAL TRIAL Topics As Interview Questions?

  • @ankitadas6256
    @ankitadas6256 5 місяців тому

    It's Awesome. Thanks Sir.

  • @varadkale2666
    @varadkale2666 5 місяців тому

    Please upload part 3

  • @goodthingsmotivation1776
    @goodthingsmotivation1776 6 місяців тому

    Sir please don't Stop because of views you are doing well

  • @goodthingsmotivation1776
    @goodthingsmotivation1776 6 місяців тому

    Thank you so much sir this will help us lot

  • @pharmacy940
    @pharmacy940 6 місяців тому

    Sir your linkdin id? Is there any vacancies for CTA role. Currently I am working as CRC in PGIMER Chandigarh from last 6 month

  • @nileshmarkad1518
    @nileshmarkad1518 7 місяців тому

    Thank you for starting this course 👍👏

  • @prasadbhosale3198
    @prasadbhosale3198 7 місяців тому

    Can fresher candidate join etmf domain

  • @PRASADBHOSALE-i7w
    @PRASADBHOSALE-i7w 7 місяців тому

    Can fresher do job as clinical documents specialist

  • @PRASADBHOSALE-i7w
    @PRASADBHOSALE-i7w 8 місяців тому

    Can freshers candidate apply or only experience candidate apply

    • @VikasSinghPharmalive
      @VikasSinghPharmalive 8 місяців тому

      Freshers are eligible for this position.. Companies like TCS,Cognizant,Trans perfect usually hire Freshers for this position

  • @ReenaThakur-w8w
    @ReenaThakur-w8w 8 місяців тому

    Thanks Vikas it was informative video .

  • @tchanganiskitsmalawi5067
    @tchanganiskitsmalawi5067 9 місяців тому

    bro I need an immediately help my quiz are not submitting

  • @shobhaharishchandra
    @shobhaharishchandra 9 місяців тому

    Which course is best at msc ? Clinicl research or biochemistry

  • @03rasikababar87
    @03rasikababar87 9 місяців тому

    Is eTMF specialist experience helpful to switch in PV department?

    • @VikasSinghPharmalive
      @VikasSinghPharmalive 9 місяців тому

      No, eTMF domain is completely different from PV , you can use eTMF exp in transition to role like CTA,Project Assistant

  • @spoorthir876
    @spoorthir876 10 місяців тому

    Very useful sir

  • @prachitipashte1849
    @prachitipashte1849 11 місяців тому

    Really helpful for me

  • @kishoryadav520
    @kishoryadav520 11 місяців тому

    Nice explanation

  • @pharmacy940
    @pharmacy940 Рік тому

    Salary after 3 to 5 yr of CRA

  • @pbsclinicalresearchpharmac3569

    Solicited and unsolicited galat Diya hai

  • @marathipharma.1880
    @marathipharma.1880 Рік тому

    Sir tmf or isf is same or not?

    • @VikasSinghPharmalive
      @VikasSinghPharmalive Рік тому

      No both are different ...as ISF mainly contain minimum list of essential document that need be maintained throughout the trial while TMF is compilation of all essential document

    • @marathipharma.1880
      @marathipharma.1880 Рік тому

      @@VikasSinghPharmalive That is, the documents to be filed in clinical trials, for example, if we look at the ADR form, the demographic form. At the same time, CRFs are all documents that they are. In ISF. And after this document has been filed and completed, it is us. We file the trial master file in the sponsor's or Cro's. Which is with the sponsor or CRO. Write or wrong sir?

    • @VikasSinghPharmalive
      @VikasSinghPharmalive Рік тому

      @@marathipharma.1880 trial master file mainly maintained by Sponsor/Cro while ISF need to be maintained by clinical site (I.e where actual clinical trial conducted)

    • @marathipharma.1880
      @marathipharma.1880 Рік тому

      @@VikasSinghPharmalive thank you so much sir for your precious response, 🙏 I understand.

    • @VikasSinghPharmalive
      @VikasSinghPharmalive Рік тому

      @@marathipharma.1880 you're welcome 😀

  • @krishnaveni-bn9nx
    @krishnaveni-bn9nx Рік тому

    Thank you so much……. Great explanation….Don't get disappoint for less views….. Knowledge never fades…..your hard work pays off.…

  • @gaurav_05_
    @gaurav_05_ Рік тому

    IECis -Independent ethics committe

  • @DENTOVILLAOFFICIAL
    @DENTOVILLAOFFICIAL Рік тому

    sir plz started pharmacovigilance series

  • @DENTOVILLAOFFICIAL
    @DENTOVILLAOFFICIAL Рік тому

    Sir... ye course ka Naya link hogakya.... uppar ka do link time out ho gaya

  • @pragatinishad2350
    @pragatinishad2350 Рік тому

    Can you please let me know that how comparison is done in phase 3 if there is no current treatment available for a given disease?

  • @arnabmanna7436
    @arnabmanna7436 Рік тому

    Thank for sharing the information. Are clinical process coordinator and cta same? How is the workload in clinical process coordinator?

  • @cretivevlogs3181
    @cretivevlogs3181 Рік тому

    Good content

  • @workonyourself7836
    @workonyourself7836 Рік тому

    Hindi to English is very helpful ❤😊

  • @workonyourself7836
    @workonyourself7836 Рік тому

    Thank you your video is very helpful

  • @workonyourself7836
    @workonyourself7836 Рік тому

    Thank u sir your lecture is very helpful

  • @kshitijghumatkar2302
    @kshitijghumatkar2302 Рік тому

    Very informative

  • @amarjotbhatia3847
    @amarjotbhatia3847 Рік тому

    Hello sir , is the protocol deviation is an issue faced by monitors during audit ? Please reply asap

  • @diksharao4505
    @diksharao4505 Рік тому

    I am pharma graduate and I am currently working as Clinical data manager, will this course be beneficial for me

  • @octavio1276
    @octavio1276 Рік тому

    😌 'Promosm'

  • @gayatritikar.8940
    @gayatritikar.8940 Рік тому

    Nicely explain👍

  • @mohammedghouse8559
    @mohammedghouse8559 Рік тому

    Could you clarify,we send IP before SIV visit or we can plan the IP should be receipt during SIV. Hope i will get response.

    • @bilalansari166
      @bilalansari166 10 місяців тому

      Ideally it should be sent before SIV. But if it is received during the SIV too then it's fine..

  • @rinkup9069
    @rinkup9069 Рік тому

    sir, please dont give background music, if possible. it causes distraction and unclearance of topic. and plz explain in hindi

    • @VikasSinghPharmalive
      @VikasSinghPharmalive Рік тому

      Thanks for the feedback😀 and as most of the subscriber were asking to upload video in english but no worries will upload video in both language

    • @rinkup9069
      @rinkup9069 Рік тому

      @@VikasSinghPharmalive ok sir, thank you