Clinical Research Study Start Up Regulatory Documents Explained Quickly!

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[@shameerahray-moody7135]

Thank you so much for adding this topic because I am currently a CTC-L and I am having an interview for a Study Start up Associate. I’m nervous but I’m going to knock it out!! I have been watching you for over 3 years you have truly helped me in my career in Research. Thank you so much. I’m still watching. The sky is my limit in Research thanks to you and your videos!

[@dansfera]

I appreciate it and you will do great

[@daviddelcollo9554]

Keep up doing these man...you are really making a difference through educating.....

[@victorandres9094]

I'm just starting my journey in CRA, thank you for providing these videos 👍

[@axs7689]

I really appreciate your videos I had a few hiccups in my career in clinical research but I'm very passionate in joining this field and you have been an immense help. thank you

[@forumbhanushali8207]

Hey @dansfera great video… I have been following you for a while and enjoy watching you talk about these essential operations at site level in such a clear and direct manner. Just wanted to add one more point - In case of Ex-US sites, we also generally include the Translation Certificate depending on the country.

[@virirdz7316]

Omg this video is gold!! I am going to have and interview for SSU associate and it helps a lot!!! Thank you so much for share your knowledge, greetings from Mexico!! Ps. I love your can with a Mexican bill printed on it😂❤❤

[@MsChocolatyChocolate]

Great video thank you 😊

[@nnemka450]

This is soooo helpful!! I have an interview for a reg study start up associate and this is super informative!

[@dansfera]

Good luck!!

[@aprilgarrett960]

Thank you!

[@DavidGonzalez-lc9rt]

Hi Dan. You forget to add the Clinical Trial Agreement between the Sponsor/CRO and site has to be executed before SIV or activation of the site. Anyway Good job sharing Clinical trials info to all people!

[@dansfera]

Yes bad habit of saying budget and cta interchangeably

[@jayeshingale9038]

Could you please put some lite on detailed tasks performed by a CRO in study start up process? We face this type of questions regularly in a interview at any CRO.

[@gayathribalasubramanian4052]

This is super informative! Thanks for doing this !

[@dansfera]

❤️

[@dansfera]

❤️

[@user-hf9uo8yp1j]

Thank you for the information. Do you know anything about Trail Documentation Associate?

[@christineokparaki2975]

Thank you for all your videos, they are all very helpful. Can you please do a video on how to prepare stipend language from a protocol as part of start-up?

[@dansfera]

For patients?

[@solomonjunior377]

Thanks Dan for the content. Extremely necessary. However, I have an inquiry about MedRA and whether CRAs and PIs and other site staff must be familiar with its use. Thank you!

[@dansfera]

Thanks. Sounds like a specific vendor and not a universal start up activity

[@kidzeyaayamarietheres5791]

Please how can i get training and a job in study start up

[@ekhlaskhaled6413]

Thank you so much for adding this topic because I am currently engaged as astudent (DM) HOW can refillied the experiance cause still pending inspit am adding 10years but give me 144 hrs from 1500-please help me

[@ninettllerena8501]

🙌🏻

[@psd_1611]

hello sir, I am a new International student would be pursuing masters of science in regulatory affairs and graduated in chemistry ( bachelor of chemistry) . so i have a doubt regarding my concentration like in my native land i used to work as a Quality assurance officer , an IQPA officer and RN i can choose 1 concentration in RA as QA & compliances. so is it same as i worked or different than my professional experience.

[@Ozzyanaele]

Hi Dan, thanks for always sharing your knowledge. Please I'd like to know, in reviewing the FDF and it is discovered that the PI is also a stakeholder in the organization, what step(s) should be taken?

[@dansfera]

They need to disclose it on the fdf

[@Ozzyanaele]

@@dansfera Aright. But what if it's already disclosed on the FDF, is there anything else that should be done?

[@scarletttroy4246]

Me taking notes 📝 during this lecture. #superhelpful #ResearchAcademyRightHereOnKZbin

[@dansfera]

thank you!

[@dipalibendale7126]

I have one question 1. Site equipment checklist needs to be collected as a study start up document? 2. Source data access survey needs to be collected? 3.Source data agreement?

[@dansfera]

Every cro is different

[@sayali7773]

@dansfera - when the contract and budget will get negotiated ? Before SIV or During the SIV. Which role does the negotiation with site ? Sponsor CRA?

[@dansfera]

Before siv. Not cra

[@sunithapenumaka7184]

Hii sir, how will be the career as a quality assurance in clinical trails

[@dansfera]

Any way you make it best

[@hughettewatson6139]

Yup. you hit on the head!

[@dansfera]

🙏🏻

[@MzToniGenea7]

🍹☀️

[@nadeembutt4836]

I'm from the UK and applying for a role with a medical writing AI company, my question is: is there a register or a list of companies based on the number of CSR's they produce?

[@dansfera]

Clinicaltrials.gov is closest to