Hello,  I'm wondering if you all require Medical Director approval on new or major-revised forms, worksheets, etc?  An example might be manual temperature recording chart or computer downtime worksheet.  We historically have never tracked this for individual documents, just the SOPs that dictate how these are used but I am faced with the choice of making this a requirement now that we are implementing Medialab.

Thanks for any advice

It depends where you are in the world.  I never did in the UK, but I think this is necessary in the USA.

It looks like we have the Medical Director sign-off on new forms but not revised. 

11 hours ago, pinktoptube said:

It looks like we have the Medical Director sign-off on new forms but not revised. 

I know I'm in the UK, but I can't see how that works.  Surely, a thorough revision of a form could make it end up being, in effect, a new form?  Would your Medical Director have to approve that?

Neither new nor revised for us.  We do have a compliance review for new or revised and will be adding on an annual technical review.

On 9/27/2020 at 9:50 AM, Malcolm Needs said:

I know I'm in the UK, but I can't see how that works.  Surely, a thorough revision of a form could make it end up being, in effect, a new form?  Would your Medical Director have to approve that?

I suppose if it was a major revision then the procedure would have been revised which would trigger a medical director sign-off.

Many years ago, I was told by a consultant that if I modified a form, I needed a new revision number and a track of what was revised and when it went into effect.  The form was an attachment in a policy so I did have the Medical Director sign off on the change.  Something I considered minor might have been considered major by someone else. It would have been great to have a compliance review but I did not have that resource.  

Yes, our medical director signs off on major revisions/new forms. We also use MediaLab.

My current struggle is making staff understand that they may NOT copy copies of forms but must print them from MediaLab . Apparently signing in to MediaLab is too 'inconvenient' because they have to sign into their email first .?. Sigh...

 

Edited October 2, 20204 yr by AMcCord

6 minutes ago, AMcCord said:

Apparently signing in to MediaLab is too 'inconvenient' because they have to sign into their email firs

 

MediaLab has SSO, which is nice.  We have a link in our Start menu, then you get automatically logged in.  Can you explore that option?

2 hours ago, Cliff said:

MediaLab has SSO, which is nice.  We have a link in our Start menu, then you get automatically logged in.  Can you explore that option?

Great idea! Thanks Cliff.