Regulatory Open Forum

​I'm not the best person to ask, but I am at least answering, so I'll give it a shot.

There is more flexibility on IDE documentation than IND documentation, so not everyone does it the same.

I do recognize CTA, but I think of it as a business contract between the site and Sponsor or CRO.  I am someone who has always used FDA's Form 1572 for the investigator agreement.  It is actually a CDER form, but I"ve never heard of CDRH having a problem with it being used for an IDE study, since it includes all the required elements for the IDE Statement of Investigator (21 CFR 812.43(c)).

This form has space for subinvestigators and for "other facilities."  If your affiliates will enroll and assess patients, I would list any physicians who would be involved in assessing patients at those facilities as a sub-investigator.  If the affiliates pay a different role, then I'd list them as other facilities.

That's only if you were to use the Form 1572.  If not, I know of no reason that you can't incorporate the elements of the IDE Statement of Investigator into the CTA, or to prepare it as separate document, not using Form 1572.  The IDE regulations don't require that subinvestigators or other facilities be listed in the Statement of Investigator, so I don't think you have to include them.

From a business perspective, there might be a good reason to include them in the CTA, but I can't advise you on that.

But my very best advice to you is to post this question to the ACRP Forum!  Someone in your organization should be a member.  Preferably more than one somebody.  It's a much better forum for questions about clinical trials.  They can probably give you much better, more detailed, and more reliable advice than I can.

​I'm not the best person to ask, but I am at least answering, so I'll give it a shot.

There is more flexibility on IDE documentation than IND documentation, so not everyone does it the same.

I do recognize CTA, but I think of it as a business contract between the site and Sponsor or CRO.  I am someone who has always used FDA's Form 1572 for the investigator agreement.  It is actually a CDER form, but I"ve never heard of CDRH having a problem with it being used for an IDE study, since it includes all the required elements for the IDE Statement of Investigator (21 CFR 812.43(c)).

This form has space for subinvestigators and for "other facilities."  If your affiliates will enroll and assess patients, I would list any physicians who would be involved in assessing patients at those facilities as a sub-investigator.  If the affiliates pay a different role, then I'd list them as other facilities.

That's only if you were to use the Form 1572.  If not, I know of no reason that you can't incorporate the elements of the IDE Statement of Investigator into the CTA, or to prepare it as separate document, not using Form 1572.  The IDE regulations don't require that subinvestigators or other facilities be listed in the Statement of Investigator, so I don't think you have to include them.

From a business perspective, there might be a good reason to include them in the CTA, but I can't advise you on that.

But my very best advice to you is to post this question to the ACRP Forum!  Someone in your organization should be a member.  Preferably more than one somebody.  It's a much better forum for questions about clinical trials.  They can probably give you much better, more detailed, and more reliable advice than I can.

​I'm not the best person to ask, but I am at least answering, so I'll give it a shot.

There is more flexibility on IDE documentation than IND documentation, so not everyone does it the same.

I do recognize CTA, but I think of it as a business contract between the site and Sponsor or CRO.  I am someone who has always used FDA's Form 1572 for the investigator agreement.  It is actually a CDER form, but I"ve never heard of CDRH having a problem with it being used for an IDE study, since it includes all the required elements for the IDE Statement of Investigator (21 CFR 812.43(c)).

This form has space for subinvestigators and for "other facilities."  If your affiliates will enroll and assess patients, I would list any physicians who would be involved in assessing patients at those facilities as a sub-investigator.  If the affiliates pay a different role, then I'd list them as other facilities.

That's only if you were to use the Form 1572.  If not, I know of no reason that you can't incorporate the elements of the IDE Statement of Investigator into the CTA, or to prepare it as separate document, not using Form 1572.  The IDE regulations don't require that subinvestigators or other facilities be listed in the Statement of Investigator, so I don't think you have to include them.

From a business perspective, there might be a good reason to include them in the CTA, but I can't advise you on that.

But my very best advice to you is to post this question to the ACRP Forum!  Someone in your organization should be a member.  Preferably more than one somebody.  It's a much better forum for questions about clinical trials.  They can probably give you much better, more detailed, and more reliable advice than I can.

​I'm not the best person to ask, but I am at least answering, so I'll give it a shot.

There is more flexibility on IDE documentation than IND documentation, so not everyone does it the same.

I do recognize CTA, but I think of it as a business contract between the site and Sponsor or CRO.  I am someone who has always used FDA's Form 1572 for the investigator agreement.  It is actually a CDER form, but I"ve never heard of CDRH having a problem with it being used for an IDE study, since it includes all the required elements for the IDE Statement of Investigator (21 CFR 812.43(c)).

This form has space for subinvestigators and for "other facilities."  If your affiliates will enroll and assess patients, I would list any physicians who would be involved in assessing patients at those facilities as a sub-investigator.  If the affiliates pay a different role, then I'd list them as other facilities.

That's only if you were to use the Form 1572.  If not, I know of no reason that you can't incorporate the elements of the IDE Statement of Investigator into the CTA, or to prepare it as separate document, not using Form 1572.  The IDE regulations don't require that subinvestigators or other facilities be listed in the Statement of Investigator, so I don't think you have to include them.

From a business perspective, there might be a good reason to include them in the CTA, but I can't advise you on that.

But my very best advice to you is to post this question to the ACRP Forum!  Someone in your organization should be a member.  Preferably more than one somebody.  It's a much better forum for questions about clinical trials.  They can probably give you much better, more detailed, and more reliable advice than I can.

​I'm not the best person to ask, but I am at least answering, so I'll give it a shot.

There is more flexibility on IDE documentation than IND documentation, so not everyone does it the same.

I do recognize CTA, but I think of it as a business contract between the site and Sponsor or CRO.  I am someone who has always used FDA's Form 1572 for the investigator agreement.  It is actually a CDER form, but I"ve never heard of CDRH having a problem with it being used for an IDE study, since it includes all the required elements for the IDE Statement of Investigator (21 CFR 812.43(c)).

This form has space for subinvestigators and for "other facilities."  If your affiliates will enroll and assess patients, I would list any physicians who would be involved in assessing patients at those facilities as a sub-investigator.  If the affiliates pay a different role, then I'd list them as other facilities.

That's only if you were to use the Form 1572.  If not, I know of no reason that you can't incorporate the elements of the IDE Statement of Investigator into the CTA, or to prepare it as separate document, not using Form 1572.  The IDE regulations don't require that subinvestigators or other facilities be listed in the Statement of Investigator, so I don't think you have to include them.

From a business perspective, there might be a good reason to include them in the CTA, but I can't advise you on that.

But my very best advice to you is to post this question to the ACRP Forum!  Someone in your organization should be a member.  Preferably more than one somebody.  It's a much better forum for questions about clinical trials.  They can probably give you much better, more detailed, and more reliable advice than I can.